Precision For Medicine

Associate

• Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents.
• Will work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations.
• Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendor contracts and site budgets.
• Lead interactions with the North American and European internal study teams, as applicable
• Lead interactions regarding the various agreements with the Site(s)
• Lead interactions regarding assigned agreements with the Sponsor(s)
• Work with supervisor and various internal/external stakeholders to resolve contractual issues.
• Ensure adhered to company policies, procedures, and contracting standards.
• Update relevant study team members and sponsors regarding the status of contract negotiations and execution.
• Coordinate execution of the agreements
• Support the maintenance of contract files and databases, including email and document archiving.
• Other duties as assigned.

Senior Contracts and Budget Associate – FSP

Clinical Research

• The Manager Clinical Trial Management (MCTM) offers an additional development path for clinical research professionals. Responsibilities focus on the management and career development of the organization’s Clinical Trial Managers (CTM, Sr. CTM, and Principal Clinical Trial Managers (PCTM) , as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Clinical Trial Management operations.
• This position requires the ability to independently lead, manage, and motivate a team of CTMs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. The Manager will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
• Develop, mentor, coach and manage CTMs, and PCTMs to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development
• Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CTM expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs)
• Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met
• Generate action plans and provide developmental/strategic oversight to optimize CTM services, with a focus on high quality delivery of individual/team/departmental goals
• Provide on-going feedback and development to manage the performance of direct reports.
• Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CTMs
• Ensure all assigned CTMs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position
• Ensure CTMs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements
• Ensure CTMs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance
• Perform other duties and departmental initiatives as assigned by Leadership

Manager, Clinical Trial Management

Events

• Coordinate and support the execution of a diverse range of in-person and virtual events including conferences, trade shows, webinars, regional field activations, and client engagements, in alignment with the organization’s event calendar and strategic objectives.
• Support the execution of conferences and events by managing key logistics including venue coordination, vendor engagement, registration, team accommodations, promotional efforts, marketing collateral, budget tracking, and post-event wrap-up.
• Collaborate with cross-functional teams including executive leadership, sales, and practice areas, to support the execution of established event strategies.
• Utilize and maintain marketing technology platforms such as HubSpot, Salesforce, and iCapture to support campaign management tracking in close collaboration with the marketing operations.
• Support event execution in alignment with established budgets, timelines, and performance metrics, ensuring adherence to strategic goals.
• Collaborate with the broader marketing team to ensure event strategies are fully integrated into multi-channel marketing campaigns.
• Oversee the development of event-related promotional copy and creative assets in partnership with the creative team, ensuring alignment with campaign objectives across emails, social media, and marketing materials.
• Manage onsite event logistics including setup, vendor coordination, attendee engagement, booth or session management, and post-event teardown to deliver a seamless and professional experience.
• Bring creative thinking and a solutions-oriented mindset to enhance event-integrated marketing campaigns, contributing fresh ideas and innovative approaches across pre-, during-, and post-event phases in collaboration with the creative and marketing teams.
• Ensure brand consistency and compliance with industry regulations across all event materials and communications.
• Conduct post-event evaluations to measure impact, uncover improvement opportunities, and deliver actionable insights to the marketing team.
• Excellent interpersonal skills with the ability to collaborate effectively across diverse personalities and work styles.
• Some travel to major trade shows may be necessary.

Marketing Manager – Events

Compliance

• The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics.
• Translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization.
• Serve as the CDx regulatory subject matter expert for strategic positioning of client programs.
• Proactively identify client needs by understanding the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives.
• Lead consulting engagements with pharmaceutical clients to develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives.
• Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations.

Director, CDx Regulatory Consultant

Research Analyst

• Monitor and own the progress of clinical studies at investigative sites
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.)

Clinical Research Associate II

Safety Specialist

• Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.
• Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
• Participate in the assessment and set-up of a safety database to capture SAE data.
• Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
• QC of documents and safety reports.
• Preparation and/or review of project-specific safety reporting plans and medical coding plans.
• Preparation and/or review of safety training materials.
• Provide safety training and oversight for consultants, contractors and/or staff.
• Review and/or draft standard operating procedures and work instructions.
• Assist clients and/or other departmental staff with safety-related reviews and other services.
• Other duties as assigned.

Drug Safety Specialist II

• Perform all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs.
• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program specific safety plans
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability
• Enters data into Argus Safety Database
• Code events, medical history, concomitant medications and tests
• Draft case narratives
• Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved
• Participates in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
• Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
• Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects
• Participates in audits/inspections as required
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings
• Participates in project specific teleconferences/meetings as required
• Other duties assigned by management

Safety Specialist II

General

• Provide overall support to study sites and clinical project teams engaged in clinical research studies
• Adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements
• Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools
• May assist in identifying study sites by performing site feasibility and recruitment tasks
• Schedules internal and external meetings as required
• Prepares Investigator Site Files including distribution to study sites
• Performs ongoing essential document collection and review
• Organizing and maintaining site level data in the trial master file (TMF)
• Perform set ups and maintain site-related data in applicable clinical systems
• Acts as site contact/liaison for study and site management issues
• Ensures timely and complete data entry by site in EDC
• Sends email blasts/newsletters and updates to study site personnel
• Assists in providing logistics support in samples management and tracking
• Supports investigators in fulfilling obligations regarding local submissions
• Assists in data review inclusive of site level data review
• Assist with study tracking via the CTMS
• Documents site and Sponsor contact and study interactions in a timely manner
• Assist in remote review of the electronic Investigator Site File
• Assists with Investigational Product accountability
• Consults with project team members regarding study site issues
• Provides quality review of the amended site level informed consent template
• Follows up with sites for trial invoices

In-House CRA II

• Develop, negotiate global study budgets based on the requirements of a study protocol.
• Review, draft and negotiate a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements
• 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.
• Coordinate execution of agreements
• Support the maintenance of contract files and databases, including contract archiving.
• Recognize where processes can be improved and take corrective action.
• Other tasks, as assigned.

Contract & Budget Associate

Auditor

• Support the Quality Management System including SOPs, training and CAPA
• Process and maintain documentation for controlled documents, as required
• Develop and administer training for employees and/or consultants
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct internal audits of quality systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Participate on computer systems validation projects and systems change control process
• Provide QA consultation and support to assigned project teams internally and externally
• Support and manage reported quality issues and any associated corrective and preventive actions
• Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
• Maintains Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures

Senior GCP Process Auditor

• Support the audit program and clinical projects to ensure compliance with regulations and Precision procedures
• Provide oversight and subject matter expertise to quality and compliance activities
• Support project teams during all stages of a clinical study
• Support the Quality Management System including SOPs, training and CAPA
• Process and maintain documentation for controlled documents, as required
• Develop and administer training for employees and/or consultants
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct internal audits of quality systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Participate on computer systems validation projects and systems change control process
• Provide QA consultation and support to assigned project teams internally and externally
• Support and manage reported quality issues and any associated corrective and preventive actions
• Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
• Maintain Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures

• Support the audit program and clinical projects to ensure compliance with regulations and Precision procedures
• Provide oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study
• Support the Quality Management System including SOPs, training and CAPA
• Process and maintain documentation for controlled documents
• Develop and administer training for employees and/or consultants
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct internal audits of quality systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Participate on computer systems validation projects and systems change control process
• Provide QA consultation and support to assigned project teams internally and externally
• Support and manage reported quality issues and any associated corrective and preventive actions
• Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
• Maintain Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards

• Support the Quality Management System including SOPs, training and CAPA
• Process and maintain documentation for controlled documents, as required
• Develop and administer training for employees and/or consultants
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
• Coordinate and conduct internal audits of quality systems
• Coordinate and conduct investigator site audits
• Coordinate and conduct trial master file audits
• Participate on computer systems validation projects and systems change control processes
• Provide QA consultation and support to assigned project teams internally and externally
• Support and manage reported quality issues and any associated corrective and preventive actions
• Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
• Maintain Q&C trackers, databases, metrics, and files
• Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures