Senior Clinical Data Manager

Fortrea•Durham, NC

2d•Hybrid

About The Position

This role involves leading Clinical Data Management (DM) on studies, taking responsibility for developing project documentation, system setup, data entry, and data validation procedures. The Senior Clinical Data Manager will act as a subject matter expert (SME) for DM activities, working directly with sponsors to understand and implement their requirements. They will also provide guidance, mentoring, and training to junior DM staff to ensure best practices are maintained. The position requires managing all DM activities from study start-up to database lock, ensuring quality, adherence to timelines, and budget management.

Requirements

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.
Speaking/Writing/Reading: English required.
8 years of combined early or late-stage DM experience.
Minimum 2 years of direct sponsor management.
At least 2 years technical mentoring experience.
Proven experience in handling customer negotiations.
Experience with managing Scope of Work and budgets.
Must have full service and CRO experience.
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.
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.
Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs.
Good organizational ability, communication, and interpersonal skills.
Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.

Nice To Haves

University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Through knowledge of Fortrea, the overall organization structure and Standard Operating Procedures (SOPs).
Four or more years of Electronic Data Capture experience.

Responsibilities

Lead studies, including those with healthy volunteer and patient populations, complex protocol designs, strong client management, or reduced timelines.
Organize and effectively prioritize workload and deliverables.
Be accountable for all DM deliverables as assigned per the established timeline, providing instruction to the DM study team and reviewing their output.
Ensure all allocated projects are carried out in strict accordance with relevant protocols, global harmonized SOPs, and GCPs.
Build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team.
Provide DM project team leadership and accountability, leading data-focused internal project team meetings.
Meet frequently with leads of EDC Design, SAS Programming, Statistics, and PK to ensure deliverables are planned and coordinated intradepartmentally.
Proactively identify potential risks/mitigations and effectively communicate data-driven discussions to achieve database lock dates.
Maintain awareness of other Biometrics functional group deliverables to support risk and mitigation strategies.
Keep Project Manager (or designee), Biometrics management team, and/or sponsor services informed of pertinent project or sponsor-related information.
Coordinate the receipt and inventory of all data-related information from clinical sites and vendors.
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 ensure Sponsor approval is received and the scope change is processed.
Provide leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
Support DM supervisors and managers on performance evaluation of other team members, providing constructive feedback.
Accountable for learning new DM technologies and applied processes, keeping up-to-date with industry-wide technology and feasibility for process improvement.
Ensure service and quality meet agreed upon specifications per the DMP and scope of work.
Have input in writing, reviewing, and updating SOPs and associated documents.
Maintain accurate records of all work undertaken.
Perform reconciliation of the clinical database against safety data, laboratory data, or any other third-party data.
Utilize local laboratory systems and batch data load facilities where appropriate.
Represent DM and Biometrics in new business opportunities.
Attend and action client or internal audits and resolve all issues within an appropriate timeframe.
Address client comments with the study team.
Develop and implement directional strategy by providing technical input and rolling out training/mentorship to DM staff.
Actively promote Biometrics services to sponsors.
Perform other related duties as assigned by management.