Senior Clinical Data Manager – Sponsor Dedicated

This is a fully remote position, open to applicants in Poland.

📋 Description

• Provides leadership in Clinical Data Management (CDM) for one or more assigned projects or indications based on the project's size and scale.

• Holds global accountability and acts as the secondary point of contact at the project level.

• Oversees studies that may involve a combination of healthy volunteers and patient populations, multi-site collaborations, complex protocol design, with a strong emphasis on client management or accelerated timelines.

• Capable of organizing and effectively prioritizing workload and deliverables.

• Exhibits leadership and operational expertise in the strategic planning and execution of CDM deliverables at both program and project levels.

• Manages and oversees vendor contracts, resources, budget management, and vendor performance for assigned programs and projects.

• Communicates and negotiates effectively with all other team members at the Program level.

• Serves as the primary point of contact for Clinical Data Management (CDM).

• Demonstrates a business understanding of the compound profile to identify and facilitate the successful application of consistent CDM processes and documentation across assigned programs, ensuring uniformity across data quality plans.

• Provides oversight and expertise to external service providers or in-house teams to ensure delivery of quality data in compliance with study model procedures and standards; offers guidance on company standards, processes, systems, and expectations to external partners, internal partners, and third-party vendors.

• Responsible for proactive risk management and issue resolution/escalation related to Clinical Data Management improvements or technology.

• Develops an understanding of CDASH and SDTM or other recognized industry standards and their impact on the programming team to ensure consistency with program-level standards.

• A specialist in therapy area-specific data capture and standards, conducts lessons learned and disseminates insights across the organization as appropriate.

• May act as a team leader or mentor to Clinical Data Management colleagues and stakeholders regarding operational processes used in studies and projects.

• Willingly takes on and leads any project-level activity that aligns with current experience in support of study delivery.

⛳️ Requirements

• University or college degree (preferably in life sciences, pharmacy, or a related field), or certification in a related allied health profession from an accredited institution.

• 8 years of combined experience in early or late-stage data management, including a minimum of 2 years in direct sponsor management and at least 2 years of technical mentoring experience.

• Proven track record in customer negotiations and managing Scope of Work and budgets.

• Extensive experience in clinical data management with a background in leading studies within a CRO or pharmaceutical setting.

• Excellent oral and written communication skills, along with strong presentation abilities.

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

• Working knowledge of the relationship and regulatory obligations between the CRO industry and pharmaceutical/biotechnology companies.

• Ability to lead teams by example, effectively implementing project strategies and achieving departmental goals, objectives, and initiatives while encouraging team members to explore solutions.

• Demonstrated managerial and interpersonal skills.

🏝️ Benefits

• Highly competitive compensation packages, including various local benefits such as pension contributions.

• Complimentary health insurance plans.

• Remote working allowances.

• A genuine work-life balance.

• Flexibility in working hours.

• Comprehensive onboarding process with support from a personal mentor.

• Permanent employment contract with Fortrea Drug Development and opportunities for rewarding career progression.