Senior Clinical Project Manager – Permanent – Pharma – UK

SCPM

Job Type: permanent
Job Category: Clinical
Area: England
Location: Unspecified
Salary: Competitive
Posted: 29th November 2021
Ref: SCPM/HLIO

Working with CROs and various vendors, lead project teams to deliver Phase III project milestones to time, cost, and quality targets, and ensure CRO and vendors deliver as per contract.  Ensure oversight of vendors is adequate to meet the standards for potential regulatory agency audits. PM accountability will be for 1-2 Phase III studies.  Position reports to the Vice President of Clinical and may have direct reports at some point during the study. This search is for a Senior Clinical Project Manager.

THIS POSITION IS BASED IN THE UK

Senior Clinical Project Manager Specific Job Duties:

·Oversee all aspects of trial conduct from Early Engagement process through study start-up, conduct, close-out and Lessons Learned

·Chair Project Team Meetings

·Participate in Vendor selections

· Manage project KPIs per the scope of work (SOW) and within the contracted budget

· Ensure project is conducted according to Bellus and CRO SOPs

· Develop plans to achieve contracted milestones (i.e., project plan, clinical management plan, monitoring plan, training plan, communication plan, Risk Register); monitor project progress against the established plans and ensure compliance with plans

· Establish weekly 1:1 meeting with key Bellus functional leads such as Clinical Trial Management, Data Management Clinical Quality Management and Vendor Management to ensure coordination of functional deliverables and serve as escalation point for Bellus project issues.

·         Maintain overall MSP project plan including all vendor deliverables and associated Bellus preclinical studies and clinical supplies.

·Working with Vendor Management, ensure project budget is tracked against contract milestones

·Coordinate with Bellus CMC to ensure clinical supplies are available when required.

·Serve as Bellus’ primary project contact with CRO for assigned study(ies)

· Provide Project Dashboard and present project status at Bellus Management Meetings, and contribute key data to Board of Director and Investor presentations,

·Contribute to Health Authority Briefing Documents and Planning Meetings

·Participate in Clinical and Regulatory Advisory Board Meetings

Requirements:

·College graduate, Master’s Degree preferred

·5-10 years direct project management experience at a CRO or sponsor

·Excellent interpersonal skills and influence management skills

·Excellent written and verbal communication skills

·Very good knowledge of regulatory requirements for trial conduct (i.e., Good Clinical Practice, ICH guidelines, etc.)

· Ability to travel occasionally

· PMP Certification preferred but not mandatory

Please contact me:

E: Hirons@barringtonjames.com

T: +441293 776644

LI: https://www.linkedin.com/in/helaina-irons-351670195/

 

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