Senior Clinical Project Manager - 12 month renewable contract - Berkshire UK

Reference: RS081220DR

Expiry Date: 21-12-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Senior Clinical Project Manager - 12 month renewable contract - Berkshire UK

Global pharmaceutical is seeking a Senior Clinical project manager on a long term contract basis.

Role will entail:

  • Accountable for the delivery of one or more studies from protocol through to study report and archiving. These can be all types of study from First in Human to Phase IV Accountable for managing the interface between Client, Phase 1 Units, CROs and other vendors to ensure assigned studies are delivered according to contract specifications, with high quality, on time and on budget.
  • Accountable for leading the internal and Joint Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation to the Program Delivery Leads.
  • The level of CPM assigned to a project (either CPM or Senior CPM) will be dependent on study complexity and type (e.g. First in Human studies), scope, size and geography.
  • Senior CPMs will be accountable for more complex studies and/or those with high visibility such as pivotal trials or challenging POC studies.

MAJOR ACCOUNTABILITIES:

  • Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the client internal and CRO/Phase 1 Unit teams.
  • If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit within or outside the SPI framework depending on the specialist need of the study.
  • At the study kick-off meeting, articulate study scope, goals, and expectations of the client to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.
  • Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making. Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final CSR.
  • Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments. Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit.
  • Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.

EDUCATION & QUALIFICATION:

  • Minimum BA/BSc
  • At least three years’ relevant experience in clinical development including team leadership.
  • Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion.
  • A Sr CPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.

If this sounds like you please contact me ASAP to discuss full job spec details.

To Apply!

To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to roland@advtalent.com. Alternatively, please press the red “Apply for position” button and follow the registration process.

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