Description
Joining Fortrea's Clinical Data Management sponsor dedicated team offers a rewarding career, a chance to work in an energetic and team-oriented workplace, and exposure within a world-leading team.
The Senior Clinical Data Manager role is a great opportunity to work within our sponsor dedicated department and have a unique relationship with a sponsor. You will be responsible for the full cycle of Clinical Data Management queries, from being in full leadership of your own studies and being the main point of contact with the client, to the most hands-on tasks such as creating eCRFs, cleaning data, and performing independently set-up to close-outs duties.
What you can expect from us
- Office based or home based anywhere in the listed countries
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances, etc.
- A genuine work-life balance
- Flexibility in working hours
- A thorough onboarding with support from your personal mentor
- A permanent employment contract with Fortrea Drug Development and a rewarding career progression
Your responsibilities
- Provides CDM leadership for one or more assigned projects or indications dependent on size and scale of the project. Takes global accountability and serves as the second line of contact at the project level
- Lead studies including a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables
- Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at program and/or project level. Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned programs, and projects
- Communicates and negotiates effectively with all other Program level team members. Primary point of contact for Clinical Data Management (CDM)
- Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned programs
- Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards; give 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 connected to Clinical Data Management improvement or technology
- Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards
- Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate
- May act as a team leader or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects
- Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery
Your profile
- University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution
- 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. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets
- Extensive experience in clinical data management and experience leading studies in a CRO/Pharma setting
- Excellent oral and written communication and presentation skills
- In-depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies
- Ability to lead teams by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
- Demonstrated managerial and interpersonal skills