Precision Medicine Group

Artificial Intelligence

• Partner with agency and functional leaders to identify opportunities to integrate AI into workflows
• Support development and execution of AI training and enablement programs
• Help create role-specific playbooks and best practices
• Coordinate AI workshops, office hours, and internal enablement sessions
• Support development of an internal network of AI champions
• Collect and organize AI use cases from teams across agencies and functions
• Maintain a structured intake and tracking system for use cases
• Categorize opportunities based on impact, feasibility, and alignment with priorities
• Partner with the AI Generalist and technical teams to support early-stage validation
• Prepare use cases for review by leadership and decision-makers
• Summarize expected benefits, required effort, and dependencies
• Support prioritization discussions and documentation of decisions
• Ensure alignment with broader AI initiatives and priorities
• Work with teams to integrate AI into existing workflows
• Support pilot execution and capture feedback
• Document successful use cases and contribute to scaling efforts
• Help standardize repeatable approaches across teams
• Gather AI-related requests, needs, and trends from client-facing teams
• Organize and synthesize inputs across agencies
• Share insights with AI leadership to inform priorities and capability development
• Help track time savings and efficiency improvements from AI use cases
• Support development of reporting on productivity and adoption
• Maintain visibility into use case pipeline progress and outcomes
• Work closely with the AI transformation team and Senior Director
• Partner with IT and architecture teams to align on feasibility and scaling
• Help ensure use cases follow the defined AI lifecycle

AI Enablement Manager

Manager

• Building and leading all aspects of project work streams
• Providing project teams with clear direction
• Managing project plans to fully meet all client deliverables
• Directing primary research with stakeholders (payers, key opinion leaders, physicians)
• Synthesizing insights and developing recommendations from primary and secondary research
• Developing relevant pricing and market access strategy
• Developing client relationships
• Attending and leading client meetings
• Helping manage client expectations
• Ensuring work product contains accurate data that is correctly cited in addition
• Developing expertise in specific areas and demonstrating such expertise by leading development of products, pitches, IP, etc.
• Contributing to certain areas of practice development (e.g., mentoring, training)

Engagement Manager, Market Access Consulting

Compliance

• Responsible for applying extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions.
• Direct the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics
• Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients
• Review and direct the development of analytical and clinical protocols, technical reports and other company documents for use in regulatory submissions and in response to queries from regulatory agencies
• Identify and collaborate with external thought-leaders and technical experts required to support research and development
• Manage, motivate, and develop staff to ensure a scalable model within the Regulatory practice as a whole

Director – IVD Regulatory Consulting

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site
• review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits.

Regulatory and Site Start Up Specialist

• Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams
• Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately
• Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability
• Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues
• Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees
• Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
• Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems
• Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution
• Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics
• Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process
• Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas
• Represent Precision for Medicine in a professional manner • Manage CRA staff in accordance with Precision for Medicine’s values and policies
• Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans

Manager, Global Clinical Monitoring – CRA Line Manager

Research Analyst

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Senior Clinical Research Associate

Project Manager

• Serve as a trusted partner to the Evidence Solutions business to lead all contract operations and see it through to project coordination
• Contract operations includes:
• Drafting and supporting the revision process on all client, vendor, and subcontractor contracts and amendments using templates and serving as the point of contact for contracting operations with our internal legal team
• Utilizing Precision’s legal platform to track and advance all documents through the contracting process from initial draft to signature and ensuring accurate and timely delivery of all contract documents to business leads for submission to clients or subcontractors
• Supporting the tracking of key terms and conditions within client MSA documents, alongside legal, to ensure that each Scope of Work (SOW) abides to the key terms of the agreement
• Tracking down purchase orders with clients as needed
• Archiving all supporting documents inclusive of signed SOWs, purchase orders, and invoices in an organized manner for the business
• Project coordination includes:
• Assisting the Project Manager by ensuring timely data capture and accuracy in the appropriate systems in relation to project setup, maintenance of project updates and resource assignment
• Serve as the primary point of contact between the finance and project teams to initiate and forecast client invoicing based on project status and contract terms
• Ensuring subcontractors and vendors have appropriate client project codes for invoice submission for ease of entry to accounts payable
• Liaising between clients and internal teams as needed to resolve invoicing questions/support
• Leading client portal setup and updates
• Additional ad hoc support as needed

Project Coordinator

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Clinical Research Associate II – FSP

• Çeşitli hukuki sözleşmelerin gözden geçirilmesi, taslağının oluşturulması, müzakeresi ve takibi
• Klinik Operasyon çalışma ekibi ile yakın çalışmak ve belirlenen çalışma takvimlerine uyumu sağlamak için kilit bir rol oynamak
• Sözleşme müzakereleri ve yürütülmesinin durumu hakkında ilgili çalışma grubu üyelerine güncellemeler sağlamak
• Sözleşme metriklerini oluşturmak, izlemek, raporlamak ve yönetmek
• Sözleşme dosyalarının ve veritabanlarının güncellenmesi ve bakımına destek olmak
• Sözleşmelerin zamanında imzalanması için politika ve prosedürlerin tasarlanması ve uygulanmasına yardımcı olmak

Site Contracts Manager

• The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.
• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversees all functional services including external vendors to the established timeline and budget
• Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate.
• Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate.
• Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality
• Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings.
• Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation
• Establish tracking metrics to monitor trial and team progress towards project goals
• Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise
• Leads both internal and client meetings and set expectations for the project team
• Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiency
• Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project
• Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required
• Perform other duties as assigned by management
• Remain compliant with organizational training, time-reporting and any other administrative duties as required
• Provides on-going feedback, for functional team members including annual performance reviews

Senior Project Manager – Oncology

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments.
• Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines.
• Serve as a subject matter expert within the department and company regarding site contract management.
• Establish process and procedures for overall site contract management in the organization.
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations.
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff

Senior Contracts Manager – FSP

Research Scientist

• Support all aspects of execution of primary data collection research studies, including literature reviews; development of data collection instruments (e.g., surveys, interview guides); study protocols; data collection; data analysis and interpretation; and support dissemination activities.
• Contribute to the development of project deliverables under the guidance of senior team members with methodological and subject matter expertise.
• Assist with the delivery of project components by collaborating with team members to ensure high-quality outputs and help maintain project timelines for assigned tasks.
• Support client engagement activities by drafting update slides for regular client meetings with guidance from senior team members, and documenting meeting notes, action items, and next steps.
• Contribute to proposal and presentation development by drafting background sections, task descriptions, timelines, and references with guidance from senior team members.

Associate Research Scientist – Evidence Generation

Program Manager

• lead the planning and execution of advisory boards, and other HCP engagements, ensuring all programs are delivered on time, within scope, and aligned with client expectations.
• partner closely with Strategic Account Directors, Scientific Directors, and Program Coordinators to manage workflows, budgets, and logistics across multiple programs.
• ownership of timelines, vendor coordination, medical/legal/regulatory (MLR) processes, and financial tracking.
• serve as a key point of contact for clients, providing regular updates and ensuring a seamless experience from planning through execution.
• mentor junior team members and contribute to overall program success and client satisfaction.

Program Manager – Medical Communications

Account Manager

• Assume primary lead for the client upon client acceptance of proposal
• Maintain and manage business opportunities with existing clients
• Development of client agendas and slide presentations
• Lead and/or support calls with client and LMR, faculty, and/or content experts regarding content and direction
• Review and forward status/contact reports to client after each client contact
• Develop project briefs and scope of work for clients and internal team members.
• Provide direction to support team on all aspects of project management to ensure client expectations are met or exceeded
• Manage projects by utilizing approved internal project briefs, proposal templates, and budget tools
• Collaborate with internal team on overall project plan, objectives, milestones, and deliverables
• Function as internal team leader ensuring all members of the team work together smoothly and effectively
• Mentor personnel at the Associate Account Executive, Account Executive, and/or Senior Account Executive levels. Depending on size of team, potential for management and supervision of colleagues.
• Conduct performance reviews, prepare development plan, and set goals for direct reports as applicable.

Group Account Supervisor – Market Access

Vice President

• Responsible for leading and developing a multi-disciplinary team in the creation, growth and execution of a multitude of capabilities and service offerings.
• Responsible for overseeing the strategic aspect of the customer’s relationship with the company, specifically focused on the customer experience
• Focuses on the methods and approaches used to interact with the customer including social media, the company’s website, telecommunications helpline and related support processes and “market presence.”
• Interjects a “customer advocacy perspective” in the design and marketing of the company’s products and services.
• Provides guidance using best-in-class knowledge of strategy, business insights and personnel development.
• Coaches and develops executive team members to grow company strategy and talent.
• Diagnoses and recognizes issues impacting the organization.
• Influences leadership to deliver strategic business goals and objectives with a planned approach, on time and on target.
• Creates and communicate technical/scientific vision and strategy for all solution areas in a professional services environment.
• Responsible for transformational change but also championing innovation across the organization.
• Provides strategic framework for the creation, positioning, branding, pricing and marketing of innovation opportunities.
• Cultivates a creative environment for the organization and disseminates innovative ideas throughout the organization.
• Delivers operating profit goals assigned to new product innovation.
• Apply AI and machine learning to elevate customer and employee experiences across digital touchpoints.
• Champion the integration of AI technologies—such as predictive analytics and automation—into experience strategies to enhance engagement, satisfaction, and operational efficiency
• Lead global expansion initiatives by aligning regional experience strategies with enterprise goals, ensuring seamless integration across markets and cultures.
• Responsibility may include direct/indirect revenue, sales and growth for the solution area.
• Promote and adhere to Precision AQ’s workplace values known as Precision Principles (Client Service, Purpose, Accountability, Mutual Respect and Collaboration)