requirements and lead implementation of those requirements.
Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea.
Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary.
Ensure all appropriate documentation and procedures are performed upon project completion.
Develop and maintain client relationships and review client satisfaction surveys.
Implement appropriate action plans including driving process improvements and team training.
Track scope changes and work with the Project Manager or FSP Lead (or designee) to ensure that Sponsor approval is received, and the scope change processed.
Maintain accurate records of all work undertaken.
Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate.
Utilize local laboratory systems and batch data load facilities where appropriate.
Address client comments with the study team.
Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines.
Requirements
Ability to organize and effectively prioritize workload and deliverables.
Qualifications (Minimum Required): University / college degree.
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree. Fortrea may consider relevant and equivalent
experience in lieu of educational requirements. Language Skills Required: Speaking/Writing/Reading: English required.
Experience (Minimum Required): 8 years of combined early or late-stage DM
experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience. Proven
experience with managing Scope of Work and budgets.
Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
Proven ability to lead by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
Ability to work in a team environment and collaborate with peers.
Ability to mentor junior members of the department, providing SME guidance on DM practices.
Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs.
Qualifications Include: University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Through knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs).
Experience
Four or more years of Electronic Data Capture experience.
Additional details
Job Overview: Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff.
Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets.
Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors.
Work directly with Sponsors to understand their direct
The Senior Clinical Data Manager will work with the leadership team to provide guidance, mentoring and training to DM to ensure best working practices are maintained. Summary of
As the Study Manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly.
Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings.
Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager or FSP Lead (or designee) apprised of project progress.
Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e., budget status, work scope changes, timeline impacts).
Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate to meet timelines for deliverables.