Clinical Program Manager

Clinical Program Manager/Clinical Project Manager/Clinical Operations/Clinical Project Leader/Clinical Trial Manager

This is an exciting job opportunity for a Clinical Program Manager with a Global Pharmaceutical company based in Cambridge. This position is to support a new Phase III trial for an anti-fungal study. This is a large study to be conducted over several countries across the globe.

Proven experience leading a Phase III clinical trial is needed, as well as multiple international trial site management.

Essential Duties and Job Functions:
*Day to day management of ongoing clinical trials
*Support management of external vendors
*Provide support/guidance for junior members of study team
*Participate in development/update of clinical documents
*Perform TMF reviews
*Assist with audit preparation and audit responses
*Review drug release packages
*Communicate project status and issues and ensure project team goals are met.
*Anticipate moderately complex obstacles and client difficulties and implement solutions
*Perform ongoing Data Management listings and data-set reviews
*Perform site evaluation visits across Europe, as needed
*Perform feasibilities, as needed
*Assist with planning of Investigator Meetings, as needed
*Travel may be required.

Knowledge, Experience and Skills:
*BSc or BA in a relevant scientific discipline and proven relevant clinical experience in the pharmaceutical industry.
*Extensive experience of clinical trial process
*Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
*Thorough knowledge and understanding of EMEA Regulations, ICH GCP, national regulations & associated EU Directives governing the conduct of clinical trials.
*Experience in management of external resources and vendor relations
*Ability to work in cross-functional teams
*Excellent interpersonal skills and demonstrated ability to work unsupervised.
*Must be able to identify and resolve problems using national and international regulations and guidelines.
*Strong communication and influence skills and ability to create a clear sense of direction.
*Experience in mentoring and developing junior staff.

Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group").

TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice.