Contract Clinical Program Manager
Proclinical have a unique chance for a Clinical Program Manager to join one of the leading pharmaceutical companies in London. You will play a pivotal role on ongoing and new clinical trials for early phase research. The post holder will work cross functionally with Supply Chain, Clinical Operations and Quality Assurance. This is a 12 month contract role with the possibility of an extension.
- Create/Review patient consent forms and provide relevant opinion
- Review Contracts with Vendors and sites, and provide relevant feedback
- Initiate Confidentiality agreements with vendors and sites
- Develop and manage feasibility questionnaires from sites, ability to track responses and evaluate risks and trends.
- Have responsibility for oversight and delivery of components of data generation
- Lead the overall initiation, coordination, implementation and management of international clinical trials from start-up to closeout.
- Manage the cross-functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met.
- Manage operational and technical aspects of projects including budgeting, study initiation and risk management.
- Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation.
- Select, manage and coordinate (i.e. including vendor performance, contracts, budgets and invoicing) external vendors
- Identification of investigational sites and coordinate co-monitoring with CRAs when required.
- Represent clinical operations on multi-function project teams internally and externally, report on study progress to Sr Management.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans.
- Ensure the delivery of the clinical study according to ICH GCP, local applicable regulations and company's specific SOPs.
- Support in writing the protocol synopsis, Protocol, ICF, and other study-related documents.
Skills and Requirements
- BSc, MSc or PhD qualified
- 7-10 years' Project Management experience within a Pharma or Biotech
- Strong Vendor/ CRO Management experience
- Budget Management experience
- Phase I-III
- CRA background is ideal but not essential
- A positive, driven and dynamic individual who is keen to work in a biotech
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.