Senior Clinical Data Manager

We are seeking a Senior Clinical Data Manager to lead studies and provide data management leadership on studies. You will be responsible for the development of project documentation, system set-up, data entry and data validation procedures and processes. You will act as a subject matter expert (SME) for DM activities in relationship meetings with Sponsors and work directly with Sponsors to understand their direct requirements.

Responsibilities:

• Lead studies including healthy volunteer and patient populations, multi-site, complex protocol design, and strong client management
• Be accountable for all DM deliverables as assigned per the established timeline
• 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) to build timelines to meet contracted milestones
• Provide DM project team leadership and accountability
• 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
• Coordinates the receipt and inventory of all data related information
• Develop and maintain client relationships and review client satisfaction surveys
• Track scope changes and work with the Project Manager or FSP Lead (or designee) to ensure that Sponsor approval is received
• Provides leadership, mentorship, and coaching in DM related clinical trial processes
• Accountable for learning new DM technologies and applied processes
• Ensures 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 as required
• 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
• 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
• Works with management team to develop and implement directional strategy by providing technical input into discussions
• Actively promote Biometrics services to sponsors whenever possible
• Performs other related duties as assigned by management

Qualifications:

• University / college degree
• 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
• 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
• 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:

• 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