Ref #: 33725

Employment type: Permanent - Full-Time

Location: Ireland

Posted: 12-Nov-2021

Description

At ICON Clinical, within our Global Strategic Solutions Team, as part of a large global Clinical Data Management FSP Partnership with a well known global Pharma company, we are currently recruiting for a number of experienced Senior DM PMs to join us in UK or Ireland.

Title: Clinical Data Management Project Manager / Senior Clinical Data Management Project Manager.
Duration: Full Time Permanent Employment
Location: Home Based in UK or Ireland

Summary:

- Lead & 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.
- Recognized as an operational expert in clinical data flow, program-level consistency, and study-level execution by all functions within assigned studies. By acting as the primary Data Management (DM) representative to the study management team, the Senior DM PM partners with the sponsor Data Management Portfolio Lead and key study/program team members to
implement study-level project plans.
- The Senior DM PM 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.
- Uses phase, TA and operational expertise to implement program and study level operational plans and oversees external data vendors to ensure on time project delivery on large and/or highly complex projects/programs. Develops study quality plans and ensures adherence and consistent execution across the data flow and within programs. Contributes to and/or accountable to update and manage
study dashboards, timelines, resource prioritization, and data deliverables.

Responsibilities:

- Manage and provide leadership to local Data Management teams to ensure project objectives are met within budget and agreed timelines.
- 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.
- 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.
- Responsible for ensuring all relevant DM documentation is filed in the eTMF for their assigned trials
- 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:
o 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.
o Accountable for quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
o Develops risk mitigation or action plans and oversees execution when appropriate.
o 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.
o Primary contact between DM and clinical study management teams (SMT). Liaises directly with stakeholders (Biometrics functions, Clinical, Medical, Regulatory Affairs)
o Is recognized as a Subject Matter Expert for DM process, data collection and management, and reporting
o Manages performance and quality issues with external data vendors (3rd party data providers such as labs) and escalates to sponsor DM Portfolio Lead and DM management. Develops appropriate risk mitigation, as needed.
o Support study-level/drug program audit and inspection readiness activities as needed
o Coordinates timelines, data deliverables and priorities across multiple studies and phases within a program or therapeutic area for all dataflow activities
o Accountable for implementing consistent operational and quality plans across multiple studies within a program and for the delivery of the overall quality of study data
o Manages performance and quality issues with external data vendors and develops appropriate risk mitigation as needed by analysing and trending vendor performance across multiple studies and phases
o Develops and Approves timeline and project manages all end to end data deliverables for assigned studies and tracks & reports progress at relevant forums
o Implement collection standards for studies ensuring consistent application across a program of studies and educates individual SMTs on how decisions applied to one study affect the final consolidated data used for integration and submission
o Trends risk and mitigation plans for each assigned study and consolidates information to provide study status for senior management and sponsor DM Portfolio Lead

Requirements:
- 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)
-Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
- Experience working on outsourced clinical trials
- Experience developing and implementing DM process and data standards
- Demonstrated ability to establish effective business process and relationships with external stakeholders, including implementing process change at a vendor

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