Senior Clinical Data Manager (Medical Device)

Join Fortrea's Medical Device & Diagnostics team and make a difference as Lead Data Manager!

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 requirements and lead implementation of those requirements. 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 Responsibilities:

• As the Lead Data 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.

• Ability to organize and effectively prioritize workload and deliverables; strong client management required.

• Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.

• Work with the Project Manager(s) (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, and Statistics as needed, 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 designee) apprised of project progress.

• Maintain awareness of other 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.

• Keep Project Manager (or designee), functional management team and/or sponsor services informed of pertinent project or sponsor related information (i.e., budget status, work scope changes, timeline impacts).

• Coordinate the receipt and inventory of all data related information, from clinical sites and vendors as appropriate to meet timelines for deliverables. 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.

• Provide leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations to the internal study team.

• Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea.

• Ensure service and quality meet agreed upon specifications per the DMP and scope of work.

• Provide input in writing, reviewing, and updating SOPs and associated documents as required.

• Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate.

• Represent DM department in new business opportunities.

• Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.

• Work with management team to develop and implement directional strategy by providing technical input into discussions and rolling out training/mentorship to DM staff (as required).

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)
• Fluent in English, both verbal and written - this is a client-facing role.

Experience (Minimum Required):

• 5-7 years of clinical DM experience required.

• Minimum of 3 years of hands-one clinical EDC system experience required.

• 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 or medical device companies.

• Time management skill and ability to adhere to project productivity metrics and timelines.

• 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.

• Good organizational ability, communication, and interpersonal skills.

• Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.

Preferred 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).

• Minimum of 2 years of direct sponsor management and 2+ years technical mentoring experience.

• Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets strongly preferred.

Physical Demands/Work Environment:

• Role is remote-based, with associated risks of repetitive strain injury (associated with keyboard operation) and eye strain (associated with VDU screen operation).

• Potential travel for cross-site support or training needs, meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay.

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