Senior Clinical 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. Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea. 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: 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. 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. 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 FSP Lead (or designee) and DM team. 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. Coordinates 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. 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. Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations to the internal study team. Provide support to DM supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills, and achievement of competency standards. Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea. 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. Represent DM and where necessary overall Biometrics 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. Works 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). Actively promote Biometrics services to sponsors whenever possible. All other duties as needed or assigned. 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. Excellent written language. 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 in handling customer negotiations and 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. 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. 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). Four or more years of Electronic Data Capture experience. Physical Demands/Work Environment: Role is office or 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. Pay Range: $85,000-$120,000 Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr Fortrea