Ref #: 26180

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 13-Jan-2021


Job Title: Senior Clinical Data Management Operations Lead
Duration: Full time Permanent
Location: UK Home Based

Position Summary

• Manage end to end clinical data flow (data acquisition from Case Report Form (CRF) development to Clinical Study Reporting (CSR) of Clinical Data) and ensures timely project execution, quality data deliverables, and prioritization of all
DM milestone delivery.
• Act as the primary Data Management (DM) representative to the study management team, the Senior DM Operations Lead partners
with the sponsor Data Management Portfolio Lead and key study/program team members to implement study-level project plans.
• Ensures all functional activities are completed by external data vendors according to specified quality standards and timelines and coordinates ongoing data management activities with external data vendors to support the flawless execution of clinical trials.
• Acts as a mentor to less experienced ICON DOCS DM peers and vendor data management team members, possesses strong knowledge of DM trial execution processes, manages complex trials, and is recognized as a DM process subject matter expert.

• Manage and provide leadership to local Data Management teams to ensure project objectives are met within budget and agreed timelines.
• Adhere to the Client/ICON SOPs, the Data Management Plan, Working Procedures and Study Specific procedures in the implementation of tasks on the study.
• Support project management of activities in all locations, liaise with project/study teams, and escalate issues to local management and global study teams in a timely manner.
• Identify and clearly articulate DM risks and mitigation efforts, proactively applying contingencies wherever and whenever needed. Can identify the appropriate parties for escalation and can judge when to escalate further if needed.
• Provide resource projection and/or changes on an ongoing basis to ICON DOCS Management as appropriate.
• Support and Mentor direct/indirect reports and extend technical expertise on an ongoing basis.
• Identify process gaps and suggest process improvements (internal/external) on an ongoing basis.
• Develop, deliver and represent DM study specific presentations as required.
• Participate in internal / external / sponsor audits of assigned studies and manage findings through resolution both operationally and within the Quality Management System.
• Accountable for development of timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and external data vendors on assigned studies.
• Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees supporting DM personnel, and monitors and reports on overall study progress.
• Accountable for quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
• Develops risk mitigation or action plans and oversees execution when appropriate.
• Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Sponsor Portfolio Lead.
• Primary contact between DM and clinical study management teams (SMT). Liaises directly with stakeholders (Biometrics functions, Clinical, Medical, Regulatory Affairs)
• Is recognized as a Subject Matter Expert for DM process, data collection and management, and reporting.

• 8 + years Relevant Clinical Data Management experience.
•Previous experience and proven competence in managing study delivery through full DM lifecycle (planning, start-up, conduct, lock and closeout)
• Deep understanding of drug development and biopharmaceutical industry required
• Strong project management skills, and ability to effectively lead and collaborate with various business functions
•High attention to detail including proven ability to manage multiple, competing priorities
• Experience working on outsourced clinical trials
• Experience developing and implementing DM process and data standards

To apply or learn more, please get in contact with Pradeep Garepalli at DOCS Global.

Please note that we can consider only those applicants that are authorised to work in UK.