Associate Clinical

• Study Leadership:

  Lead data management aspects of clinical trials, including studies involving healthy volunteers and patient populations. Ensure effective prioritization of workloads and adherence to deadlines.

• Project Delivery:

  Accountable for all Data Management deliverables, providing guidance to the DM study team to meet established timelines. Review study team outputs to ensure high quality and adjust resource allocations as necessary.

• Compliance Standards:

  Ensure that all allocated projects are executed in compliance with relevant protocols, global SOPs, and GCP standards.

• Timeline Management:

  Collaborate with Project Managers to develop timelines that align with contracted milestones, and actively manage project deliverables.

• Team Leadership:

  Provide leadership and accountability to the DM project team. Lead internal meetings, identify potential risks, and ensure proactive communication to achieve key milestones, such as database lock dates.

• Risk Mitigation:

  Work with cross-functional leads (e.g., EDC Design, SAS Programming, Statistics, PK) to identify risks and mitigation strategies that could impact timelines, resources, and deliverables.

• Client Relations:

  Build and maintain strong relationships with clients, review client satisfaction surveys, and address any concerns regarding project progress or deliverables.

• Scope Management:

  Track scope changes, ensure sponsor approval is obtained for any changes, and ensure accurate processing of scope adjustments.

• Mentorship:

  Provide mentorship and coaching to DM team members on clinical trial processes, data management practices, and career development.

• Technology Process Improvement:

  Stay updated on new data management technologies and industry trends. Implement process improvements to enhance operational efficiency at Fortrea.

• Database Reconciliation:

  Reconcile clinical databases with safety, laboratory, or third-party data to ensure data accuracy and completeness.

• Business Development:

  Represent DM in new business opportunities, promoting the capabilities of Fortrea s biometrics services to potential clients.

• Audit Compliance:

  Participate in audits and ensure that all audit findings are addressed within specified timelines.

Qualifications:Education Experience:

• Required:

• University/College degree (or equivalent experience).
• Minimum of 6 to 8 years of experience in Data Management (DM), with at least 1 year in direct sponsor management.
• Familiarity with managing Scope of Work (SOW) and budgets.
• In-depth knowledge of clinical trial processes, DM, clinical operations, biometrics, and relevant system applications.

• Preferred:

• Experience in client relationship management and handling customer concerns.
• Knowledge of medical terminology and GCP.

Skills Competencies:

• Leadership:

  Proven ability to lead and mentor teams, and collaborate across cross-functional departments.

• Project Management:

  Strong organizational and time management skills; ability to prioritize and adhere to deadlines.

• Communication:

  Excellent oral and written communication skills; effective at managing client interactions and internal team communications.

• Problem-Solving:

  Ability to identify risks, propose mitigations, and make data-driven decisions to ensure project success.

• Technical Proficiency:

  Proficient in clinical data management tools and technologies, with experience in database management, clinical trial management systems (CTMS), and relevant software