Principal Clinical Data Manager - Multiple Sponsors, Late Phase

Home-basedwith flexibility for office-based working if preferred, depending on your location.

Are you an experienced Clinical Data Manager who is now looking to be more involved within bid defense, resource management and advising Senior DMs, in a Principal Clinical Data Manager opportunity? This is a great opportunity for someone who wants to advance their Data Management exposure, working alongside the leadership team in a technical and non-managerial DM role.

Description

• You will be permanently employed by Labcorp Drug Development working in our Clinical Development Services (CDS) division working across multiple Sponsors and multiple therapeutic areas in Phases IIb to IV.
• Office based or home based anywhere in Europe or South Africa.
• You must have previous experience of working in a lead clinical data management role within clinical research.
• Candidates must be fluent in English language (both verbal and written).

Join our growing team and discover your extraordinary potential by working as a Principal Clinical Data Manager within our Global Clinical Development department. You will act as the SME for DM activities in relationship meetings with Sponsors, working directly with them and lead the implementation of their requirements.

As Principal Clinical Data Manager, you will work alongside the leadership team to provide guidance, mentoring and training to the DM team. You will lead multiple studies and take responsibility for the development of project documentation, system set up, data entry & validation.

You will be a key member of the DM team, joining bid defenses, capabilities presentations and other client engagements regarding budget, scope or DM processes.

Other duties will include:

• Lead a variety of complexed studies, including healthy volunteer and patient populations, multi-site, involving complex protocol design.
• Be accountable for all DM deliverables, as assigned per timeline, providing instruction to their DM study team and reviewing completed work.
• Ensure all projects are completed according to relevant protocols, SOPs and GCP standards.
• Work with Project Managers to build timelines to meet contracted milestones via communication with other Data Managers and during study initiation meetings.
• DM project leadership and accountability, lead DM internal meetings, meet frequently with study leads of EDC Design, SAS Programming, Stats & PK to ensure all deliverables are planned and coordinated.
• Identify risks/mitigations, effectively communicates to ensure database lock dates are achieved.
• Develop and maintain client relationships, drive process improvements and team training.
• Support Managers with regards to performance evaluation of other team members, aid their career development.
• Support budget development process for DM opportunities.

Education

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Additional relevant work experience will be considered in lieu of formal qualifications.

Experience

• Extensive work experience in data management, including direct sponsor management and technical mentoring experience.
• Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives to encourage team members to seek solutions.
• Demonstrated skill for technical management of staff.
• In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
• Experience representing DM in bid defense meetings, providing innovative solutions.
• 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.

MORE INFORMATION AVAILABLE ON REQUEST

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