Senior Clinical Data Manager – Sponsor Dedicated

This is a fully remote position, open to applicants in Poland, +6 more countries.

📋 Description

• Deliver leadership in Clinical Data Management for one or more assigned projects or indications.

• Assume global responsibility and act as the secondary contact at the project level.

• Oversee studies involving healthy volunteers and patient populations, multi-site studies, complex protocol designs, strong client management demands, or expedited timelines.

• Organize and prioritize workload and deliverables effectively.

• Plan and execute Clinical Data Management deliverables at both the program and project levels.

• Manage and supervise vendor contracts, resources, budgets, and vendor performance.

• Communicate and negotiate with team members at the program level.

• Act as the main point of contact for Clinical Data Management matters.

• Implement consistent Clinical Data Management processes and documentation across assigned programs.

• Supervise external service providers and in-house teams to ensure quality data delivery in line with procedures and standards.

• Offer guidance on company standards, processes, systems, and expectations.

• Identify and manage risks, resolving or escalating issues pertaining to improvements in Clinical Data Management or technology.

• Gain an understanding of CDASH, SDTM, and other established industry standards and their implications for programming teams.

• Conduct reviews on data capture and standards specific to therapeutic areas and share insights.

• Mentor colleagues and stakeholders within Clinical Data Management.

• Lead project-level activities that facilitate study delivery.

⛳️ Requirements

• Preferred university/college degree in life science, pharmacy, or a related field, or certification in an allied health profession from a recognized institution.

• A minimum of 8 years of cumulative experience in early or late-stage Data Management.

• At least 2 years of direct experience in sponsor management.

• Minimum of 2 years of experience in technical mentoring.

• Established track record in customer negotiations.

• Experience in managing Scope of Work and budgets.

• Extensive background in clinical data management.

• Experience in leading studies within a CRO/Pharma environment.

• Exceptional oral and written communication and presentation skills.

• Comprehensive understanding of the clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications.

• Working knowledge of the relationships and regulatory responsibilities of the CRO industry with pharmaceutical/biotechnology companies.

• Ability to lead teams by exemplifying project strategies and achieving departmental goals, objectives, and initiatives.

• Proven managerial and interpersonal skills.

🏝️ Benefits

• Highly competitive compensation packages.

• Pension contributions.

• Complimentary health insurance plans.

• Remote working allowances.

• Work-life balance.

• Flexibility in working hours.

• Comprehensive onboarding supported by a personal mentor.

• Permanent employment contract with Fortrea Drug Development.

• Opportunities for career advancement.

• Mentoring, training, and personalized development planning.