Precision For Medicine

Manager

• Perform allocation and assignment of global resources in complex staffing scenarios for multiple departments
• Work with stakeholders and senior leadership to understand complex resource requirements
• Identify strategies to meet current and future needs
• Proactively identifies capacity constraints and hiring needs for department leaders
• Negotiates and resolves staffing conflicts in collaboration with stakeholders
• Partners with department leadership on implementing process improvements and initiatives
• Prepare metrics and summary reports on resourcing activities as necessary
• Escalate sensitive or high-risk staffing situations to Resource Management leadership and Executive Team as necessary
• Mentors others when required
• Supports leadership with strategy
• Other duties as assigned

Senior Resource Manager

Compliance

• Lead and maintain GCP quality assurance programs to ensure compliance with FDA, EMA, and ICH regulatory requirements.
• Provide ICH/GCP compliance guidance throughout the clinical development life cycle.
• Plan, oversee, and conduct GCP audits including but not limited to qualification and re-qualification of vendors, internal process, site, TMF and other document audits.
• Manage Quality and Compliance functional activities, including implementation and management of the QMS, inclusive of SOPs, Training and CAPAs.
• Work closely with the Quality and Compliance staff and Operational Functions to provide strategic compliance advice and guidance.
• Initiate the process of follow-up when suspicion of suspected scientific misconduct/serious non-compliance.
• Review clinical and nonclinical documentation to ensure regulatory compliance, data integrity, and adherence to GCP standards.
• Oversee quality events, deviations, and CAPA processes related to GCP activities.
• Lead and support global health authority inspections.
• Provide GCP guidance and training to cross-functional teams to promote a culture of quality and regulatory compliance.
• Lead and develop Clinical QA staff while supporting continuous improvement of GCP and quality systems.
• Supervisory responsibility of Quality & Compliance employees (where applicable).
• Provide quality support to Sponsors in line with established or new Quality Agreements (where applicable).
• Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g., PMDA, MHRA, etc.).
• Provide ICH/GCP guidance, auditing advice and training to internal and external clients.
• As part of the Management Team, help counsel on and direct quality initiatives to provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally.
• Support and enhance Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises, including bid defense meetings and project kick-off meetings.
• Review/audit documents intended for submission to the FDA or other regulatory agency or body to assure compliance with regulatory standards.
• Build upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients.
• Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine.
• Maintains current knowledge of regulations and guidance documents, providing expert analysis to project
• Other duties as assigned.

Senior Director, Quality & Compliance

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements.
• Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• 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.
• 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.

Site Contracts Manager

• Review, draft, and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• 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.
• 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.
• Other tasks as assigned.

• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• 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.
• 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.

• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• 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.
• 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.
• Other tasks as assigned.

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements.
• Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines.
• Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts.
• Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
• 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.
• 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.
• Other tasks as assigned.

Project Manager

• Works cross functionally to develop partnership strategies for clinical trials and programs and works closely with our project teams to provide oversight, strategic expertise in the planning, coordination, and delivery of all activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished.
• Direct, manage and ensure collaboration within a team Project Directors and Project Managers in the planning, execution and governance of projects/portfolios on a global platform
• Provide leadership and oversight on all clinical programs and in some unique cases, manage activities
• Interact with study sponsors as primary point of escalation beyond project management
• Optimize the profitability of the Project Management organization to meet or exceed budget targets
• Assess and manage resource allocations to ensure that established cost, time, and quality goals are met
• Select, train, develop and manage the performance of talent in project leadership positions (Project Directors and Project Managers)
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned project managers
• Identify and escalate impacts to project scope, resources, schedule or budget through standard methods
• Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance
• Understand and manage project/program inter-dependencies to achieve program milestones/deliverables
• Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation)
• Measure and report KPIs and lead continuous improvement
• Recognize, exemplify and adhere to Precision’s values that center on our commitment to quality, our people, clients and performance
• Manage workload of supervised staff with continued assessment and adjustment as needed
• Provide on-going feedback, development and coaching of Project Directors and Project Managers including annual performance reviews

Director, Project Management – Oncology

• 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 (CA), Ethics Committee (EC) 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 as relevant
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
• 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 collaboration
• Prepare, review and manage collection of essential documents required for site activation/IMP release
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission
• Maintain communication with other key functions participating to country start up i.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
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine 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
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
• May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
• May mentor staff on local study start-up regulations, submissions, and internal procedures
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required
• Performs other duties as assigned by management

Senior Regulatory and Start Up Specialist, Mexico

Research Analyst

• Independently oversees all aspects of study site management to ensure patient safety is protected
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit
• Establishes, updates, tracks and maintains study specific trial management tools/systems
• Manages site start up procedures including the feasibility and recruitment of potential investigators
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings

Senior Clinical Research Associate – Brazil

• Independently 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
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
• Manages site start up procedures including the feasibility and recruitment of potential investigators...
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
• 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...
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors.

Senior Clinical Research Associate, Mexico

• Works cross functionally to develop partnership strategies for clinical trials and programs
• Provides oversight, strategic expertise in the planning, coordination, and delivery of all activities for designated clinical study projects
• Directs, manages and ensures collaboration within a team of Project Directors and Project Managers
• Provides leadership and oversight on all clinical programs
• Interacts with study sponsors as primary point of escalation
• Optimizes the profitability of the Project Management organization to meet or exceed budget targets
• Assesses and manages resource allocations to ensure goals are met
• Selects, trains, develops and manages talent in project leadership positions
• Provides technical support and guidance to assigned project managers
• Identifies and escalates impacts to project scope, resources, schedule or budget
• Ensures project leadership personnel work to the highest quality standards
• Participates with Business Development in opportunity development, proposals and budgeting

Director, Project Management – Autoimmune

• Serve as primary point-of-contact and primary escalation point to the client
• Coordinate and oversee 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. Independently drive the CO to completion and execution with support as needed.
• Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities
• Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on-time, accurate billing and forecasting to support business objectives.
• 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 sets 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 ongoing feedback, for functional team members including annual performance reviews

Senior Project Manager – Autoimmune

• Lead, mentor, coach, and manage CTMs/PCTMs/MCTMs to support skill development, performance, and career growth in line with Precision for Medicine quality standards.
• Provide leadership and oversight across clinical programs, including clinical trial oversight where applicable.
• Partner with Clinical Operations leadership and cross-functional teams to improve CTM processes, quality, consistency, efficiency, and KPI achievement.
• Collaborate with Resourcing to ensure appropriate staffing and resource allocation.
• Set strategic action plans and provide ongoing performance feedback, technical guidance, and developmental support to direct reports. Ensure CTMs have appropriate training, tools, systems access, and resources to meet role expectations.
• Identify quality risks, recommend corrective actions, and escalate issues as needed to leadership, PMs, and DPMs. Ensure compliance with SOPs, regulatory requirements, project plans, and quality standards.
• Develop and update Clinical Operations SOPs, templates, and work instructions; contribute to clinical documentation as needed.
• Support CTM hiring, onboarding, and training in collaboration with HR and Learning & Development.
• Promote Precision’s values and complete additional duties as assigned by leadership.

Senior Resource Manager

Senior Director, Quality & Compliance

Site Contracts Manager

Site Contracts Manager

Site Contracts Manager

Site Contracts Manager

Site Contracts Manager

Site Contracts Manager

Director, Project Management – Oncology

Senior Regulatory and Start Up Specialist, Mexico

Senior Clinical Research Associate – Brazil

Senior Clinical Research Associate, Mexico

Director, Project Management – Autoimmune

Senior Project Manager – Autoimmune

Senior Manager, Clinical Trial Management