Precision For Medicine

Project Manager

• 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. 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 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 – Autoimmune

Data Scientist

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects.
• Oversee and/or perform database development and testing.
• Ensure that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
• Ensure that clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables.
• May assist with SAS programming and quality control of SAS programs used in the Data Management department.

Senior Clinical Data Manager

People Operations

• Provide advanced operational HR support across multiple countries or complex jurisdictions.
• Lead operational delivery of organisational changes, restructures, transfers, integrations, and workforce transitions.
• Support operational readiness and implementation of country expansions and new market entry activity.
• Ensure operational consistency while balancing local legislative and cultural requirements.
• Lead or support complex employee relations matters including investigations, grievances, disciplinary matters, restructures, and sensitive exits.
• Partner with Legal and HR leadership on high-risk or legally sensitive operational matters.
• Support Works Councils, CSEs, or employee representative processes where applicable.
• Ensure operational compliance with local labour laws, consultation obligations, collective agreements, and statutory requirements.
• Act as a senior escalation point for complex operational HR matters requiring advanced judgement.
• Drive operational governance, consistency, and best practice across supported countries.
• Support development of operational frameworks, SOPs, and escalation models.
• Provide coaching and guidance to Global People Services team members.
• Partner with HRBPs and business leaders to operationalise workforce and organisational changes.
• Provide operational input into workforce planning, transformation, and business change initiatives.
• Support implementation of HR operating model improvements and operational transformation initiatives.
• Lead operational improvement initiatives across regions or functions.
• Support implementation of HR technology, automation and scalable operational processes.
• Identify operational trends, risks and process improvement opportunities.
• Contribute to broader HR transformation and governance initiatives.

Senior People Operations Partner

• Provide advanced operational HR support across multiple countries or complex jurisdictions
• Lead operational delivery of organisational changes
• Support operational readiness and implementation of country expansions
• Ensure operational compliance with local labour laws
• Act as a senior escalation point for complex operational HR matters
• Drive operational governance, consistency, and best practice across supported countries
• Support development of operational frameworks, SOPs, and escalation models
• Provide coaching and guidance to Global People Services team members
• Partner with HRBPs and business leaders to operationalise workforce and organisational changes
• Lead operational improvement initiatives across regions

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects.
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

Clinical Data Manager II – Senior Clinical Data Manager

• The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects.
• Supervise project data entry process including development of data entry guidelines, training, data entry quality, and resourcing.
• Ensure clinical data management deadlines are met with quality.
• Conduct database build UAT and maintain quality controlled database build documentation.
• Provide input, assess and manage timelines.
• Review and query clinical trial data according to the Data Management Plan.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

• Responsible and manages all aspects of the clinical trial data management process
• Ensure that clinical data management deadlines are met with quality
• Oversee project data entry process including development of data entry guidelines
• Conduct database build UAT and maintain quality controlled database build documentation
• Perform quality control of data entry
• Train clinical research personnel on the study specific CRF
• Review and query clinical trial data according to the Data Management Plan
• Liaise with third-party vendors such as external data and EDC vendors in a project manager capacity
• Identify and troubleshoot operational problems and issues
• Participate in the development and maintenance of Standard Operating Procedures (SOPs)

Clinical Data Manager II/Senior Clinical Data Manager

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• Perform other duties as assigned

• Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects
• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s)
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assess and manage timelines
• May develop CRF specifications from the clinical study protocol
• Conduct database build UAT and maintain quality controlled database build documentation
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaise with third-party vendors such as external data and EDC vendors
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• May perform quality control of data entry
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• May review Request for Proposals (RFP), proposals, provide project estimates
• Provide leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Clinical Data Manager II / Senior Clinical Data Manager

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
• May perform quality control of data entry.
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• May assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
• Oversee development of the edit check specifications and manual data review specifications.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
• Run patient and study level status and metric reporting.
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.
• Coordinate SAE/AE reconciliation.
• Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables.
• May assist with SAS programming and quality control of SAS programs used in the Data Management department.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings.
• May review Request for Proposals (RFP), proposals, provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives, where applicable.
• Trains and ensures that all data management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues.
• May present software demonstrations/trainings, department/company training sessions, present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Clinical Research

• Leading pre-award feasibility projects
• Provide detailed pre-award support to operational strategy and business development teams
• Provide feasibility analysis and input for pre-award RFPs
• Provide enrollment modelling(s) for agreed study strategy(ies)
• Undertake feasibility site outreach for pre award opportunities
• Support and/or attend BDM and client calls
• Apply process, templates and delivery standards for feasibility pre-award
• Leading post-award feasibility projects
• Provide guidance for post-award, rescue and standalone feasibility in alignment with study and client requirements
• Manage feasibility project team in all aspects pertaining to the conduct of the feasibility
• Present feasibility strategy at KOM and provide regular updates to sponsor
• Conduct the analysis of the collected site data to provide accurate site identification, enrollment modeling and study strategy (ies)
• Support Business Development in client meetings and bid defense presentation

Feasibility Manager – Post Award

Compliance

• 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
• Identify and collaborate with external thought-leaders and technical experts required to support research and development
• Review and edit regulatory communication, submission, timeline and approval requirement documents
• Apply quality systems expertise to guide clients towards successful readiness to market products
• Generate new business through your own network
• Work in conjunction with management to design and develop customized program recommendations
• Lead workshops and conference curriculums in regulatory science for in vitro diagnostics
• Advise on work orders, change orders, master service agreements and other documents
• Collaborate with business development account management team

Director, IVD Regulatory Consulting

Manager

• 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

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Senior Project Manager – Autoimmune

Senior Clinical Data Manager

Senior People Operations Partner

Senior People Operations Partner

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Clinical Data Manager II – Senior Clinical Data Manager

Clinical Data Manager II/Senior Clinical Data Manager

Clinical Data Manager II/Senior Clinical Data Manager

Senior Clinical Data Manager

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Feasibility Manager – Post Award

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