Senior Clinical Project Manager
Senior Clinical Project Manager
Location: Cambridge, UK
If you're inspired to work for a world premier biotechnology company delivering life-changing products- join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. Here, you'll have the opportunity to make a difference in people's lives every day.
As a Senior Clinical Project Manager/ Clinical Project Manager in Cambridge, UK you will play a pivotal role in planning and managing overall clinical operations for assigned clinical trial(s)/programs including timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals. You will provide matrix management of functional area representatives to cross-functional clinical trial teams (CTTs).
This role can be filled as either Clinical Project Manager or Senior Clinical Project Manager.
Major Duties and Responsibilities:
As a Senior Clinical Project Manager you will lead/oversee multiple cross-functional CTTs for complex/global studies and define and manage accountabilities for all CTT members. You will support development of Protocol Concept Sheet (PCS) and Clinical Study Protocol (CSP) and manage the vendor(s) throughout the life of assigned clinical trial(s). You will provide matrix management of functional area representatives to cross-functional clinical trial teams (CTTs).
Additional responsibilities include the following:
- Collaborate with cross-functional area heads to ensure proper resourcing for assigned trials
- Manage selection of study vendors for assigned studies and manage the vendor(s) throughout the life of assigned clinical trial(s)
- Select investigational sites with input from Clinical Development and vendors
- Review and refine Clinical Operations Plans including study monitoring and other plans
- Oversee investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs
- Lead ongoing review of data to ensure quality and consistency
- Plan and conduct investigator meetings and ad boards, etc.
- Develop and manage program timelines, budget(s) and oversees site agreement/budget negotiation process
- Oversee the submission of trial-related and essential documents to the Trial Master File
- Identify and provide solutions to clinical trial issues or risks
- Provide input into non project related activities and development of procedures as requested
- Mentor staff and serves as a resource for new employees
- Provide or facilitate training to clinical study teams on protocol specific topics
- Participate as appropriate in internal and external audits
- University degree, preferably in a biologic/scientific discipline
- Significant experience in clinical operations including strong clinical project management experience or equivalent.
- Thorough understanding of country level regulations, ICH and GCP guidelines
- Strong leadership, communication, management and organizational skills, conflict resolution, and team building skills
- Thorough understanding of cross-functional clinical processes including data management, Biostatistics, medical writing, drug safety, and regulatory affairs
- Ability to lead a cross-functional team in a matrix environment
- Strong interpersonal and negotiation skills
- Strong verbal and written communications and presentation skills
- Proven complex problem solving and decision making skills
- Line management experience
- Ability and willingness to travel 25% of the time (internationally and domestically)
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
MedImmune is an equal opportunity employer. MedImmune will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Opening date: 16th October 2017
Closing date: 15th November 2017