Company: Key People Limited
Closing Date: 09 Nov 16
Salary (£): 60,000 - 80,000
Benefits: Bonus + Extensive Benefits!
We are looking for a Senior Clinical Project Manager focusing on early development to work for our biotech client based in Cambridgeshire.
We are looking for a Clinical Project Manager and Senior Clinical Project Manager to work for our biotech client based in Cambridgeshire.
This is an fantastic opportunity to join an exciting company with strong career development.
Applicants must have protocol writing experience and phase I experience.
Major Duties and Responsibilities:
o Provide matrix management of functional area representatives to cross-functional clinical trial teams.
o Convenes and leads cross-functional clinical trial teams.
o Defines and manages accountabilities for all clinical trial team members.
o Collaborates with cross-functional area heads to ensure proper resourcing for assigned trials.
o Authors Study Protocol.
o Develop outsourcing specifications for vendor requests for proposal and scope of work agreements.
o Participate in and guides study team in vendor selection.
o May represent Clinical Operations on the Product Development Team.
o Provide clinical operational strategy for Integrated Product Development Plan.
o Manages the vendor(s) throughout the life of assigned clinical trial(s).
o Selects investigational sites with input from Clinical Development and vendors.
o Reviews and refines Clinical Operations Plans including study monitoring and other plans.
o Leads ongoing review of data to ensure quality and consistency.
o Plans and conducts investigator meetings and ad boards, etc.
o Develops and manages study budget and may develop and manage program budgets
o Oversee site agreement/budget negotiation process.
o Develops and manages study timelines and may develop and manage program timelines.
o Oversees the submission of the trial-related and essential documents to the Trial Master File.
o Identifies and provides solutions to clinical trial issues.
o Provides input into non project related activities and development of procedures as requested.
o Mentors staff and serves as a resource for new employees.
o Line management of Associate CPMs.
o Provides or facilitates training to clinical study teams on protocol specific topics.
o Participates as appropriate in internal and external audits.
o Other duties as assigned.
o Minimum of 8 years progressive experience in clinical operations including site management and monitoring or equivalent and at least 3 years of program management experience or equivalent
o Thorough understanding of country level regulations, ICH and GCP guidelines
o Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
o Demonstrate ability to lead a cross-functional team in a matrix environment
o Strong leadership, communication, management and organizational skills, conflict resolution, and team building skills.
o Potential to line manage personnel
o Ability and willingness to travel 25% of the time (international and domestic)
|Tel:||Tel: 44 (0) 1727 811634|
|Fax:||Fax: 44 (0) 1727 844838|
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