Senior Clinical Data Manager - Early Phase

Fortrea; Leeds; Hybrid; GBP 65,000 - 85,000; Full time

Job summary

A clinical research organization in the UK is seeking a Senior Clinical Data Manager responsible for leading data management activities across clinical studies. The role demands a strong background in clinical trials, project management, and client engagement. Candidates should have 8+ years of experience in data management, along with excellent leadership and mentoring abilities. This position offers a balance of remote work and office presence.

Qualifications

• 8 years of combined early or late-stage DM experience.
• Proven ability to lead project strategies and department goals.
• Working knowledge of CRO industry obligations.

Responsibilities

• Lead studies from start-up to database lock.
• Ensure projects comply with protocols and GCP standards.
• Mentor junior DM staff and provide technical guidance.

Skills

SQL

Data Collection

GCP

Master Data Management

R

Data Management

Clinical Trials

User Acceptance Testing

Data Warehouse

SAS

Oracle

Data Analysis Skills

Education

University or college degree

Experience equivalent to a bachelor's degree

Job description

Job Overview

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 processes 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 with strong client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables.
• 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) 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; lead data‑focused internal project team meetings; meet frequently with study leads of EDC Design, SAS Programming, Statistics and PK to ensure all deliverables are planned and coordinated intradepartmentally; proactively identify potential risks/mitigations, effectively communicate data‑driven discussions to achieve database lock dates; keep the Project Manager or FSP Lead apprised of project progress.
• Maintain awareness of other Biometrics functional group deliverables 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), Biometrics management team and/or sponsor services informed of pertinent project or sponsor‑related information (i.e., budget status, work scope changes, timeline impacts).
• Coordinate 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 sponsor approval is received and the scope change processed.
• Provide leadership mentorship and coaching in DM related clinical trial processes, departmental technical capabilities and associated turnaround durations to the internal study team.
• Support DM supervisors and managers on performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards.
• Be 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.
• 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; 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.
• 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).
• Actively promote Biometrics services to sponsors whenever possible.
• Performs other related duties as assigned by management.
• All other duties as needed or assigned.

Qualifications (Minimum Required)

• University or 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 of 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 or college degree (life sciences, health sciences, information technology or related subjects preferred).
• Thorough knowledge of Fortrea’s overall structure 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.

Learn more about our EEO & Accommodations request here.

Key Skills

• SQL
• Data Collection
• GCP
• Master Data Management
• R
• Data Management
• Clinical Trials
• User Acceptance Testing
• Data Warehouse
• SAS
• Oracle
• Data Analysis Skills