We are searching for an experienced Senior Clinical Project Manager to join our committed, dynamic company.
Senior Clinical Project Manager – permanent
In this role, you will be reporting to the Chief Medical Officer and managing our clinical trials to the highest quality standards. This is a full time, permanent position.
Overall responsibility for study timelines, budgets, organisation and liaison with internal staff, external vendors and CROs. Site and investigator identification and contract negotiation. Assistance with identification, qualification and selection of vendors and CROs. Preparation, review and submission of clinical trial applications to research, ethics committees and regulatory authorities. Oversight and support of CRA activities. Any other study-related activity both internally and externally to ensure quality of the study.
- Ensure that all aspects of GCP are complied with at all times through provision of training to internal staff and on-going SOP development.
- Coordinate the smooth running and monitoring of all trials by managing qualified staff, establishing audit procedures and ensuring compliant data entry into the database in a timely fashion.
- Develop systems to track trial progress and quality, including CRO and site and investigator performance, patient recruitment activity and financial management.
- Develop project timelines and manage the budget for the study.
- Organise and liaise with staff internally and with external vendors on a regular basis to ensure efficient management of the study.
- Contribute to the development and review of SOPS, protocols, CRFs and study documentation for clinical studies.
- Maintain/develop a good level of scientific knowledge with the relevant therapeutic area.
- Work with other members of the study team to share knowledge, experiences and best practices.
- Review CRA’s work on an ongoing basic (e.g. monitoring reports and other study documentation).
- Provide input into non-project work and the development of procedures.
- Participate in training and mentoring of new company members and trial-related staff.
- Oversee development and maintenance of the TMF to ensure GCP compliance and inspection readiness.
- Coordinate controlled distribution of protocol and investigator brochures and essential documents.
- Ensure identification and qualification of potential vendors, centres and investigators and establish relationships/make contacts with selected vendors, centres and investigators. Ensure confidentiality agreements are in place for all potential vendors, centres and investigators.
- Review and complete assessments of pre-selected centres and investigators, to ensure that the study requirements can be met by the potential centres.
- Negotiate and ensure completion of contracts and budget requirements for all sites in coordination with CRO. Ensure preparation and delivery of study documents (e.g. CRFs, SDV documents and study specific instructions).
- Coordinate completion of application form and submission package for all regulatory and ethical applications, including Clinical Trial Application (CTA), Investigational New Drug (IND), Research Ethics Committee application, etc. and coordinate responses to query letters. Submission of any local applications (such as R&D in the UK) for approval of each selected site, if applicable.
- Oversee and manage the execution of the Clinical Trial Protocol and inspection readiness from pre-study activities to close out and filing .
- Oversee and manage supply of nonclincal study materials (e.g. CRF, etc.) and investigational medical products to the sites. Co-ordinate the labelling, supply and return of Investigational Medicinal Product.
- Train internal and external study personnel in study specific procedures.
- Work with Data Management to ensure the quality of the study database (review of data management plans, data queries etc.).
- Ensure that sites meet agreed deadlines and budgets.
Knowledge, Skills & Abilities:
- First degree or equivalent experience (Scientific/Medical experience).
- Minimum 24 months experience as a CRA from study start up to close out.
- 1-2 year’s experience as Lead CRA or Study Manager of international trials Phase 2 to 3 from study start up to close out.
- 3-5 years international clinical trials experience with a demonstrated understanding of the clinical study process and GCP.
- Preferred experience in out-patient trials.
- Experience in anti-infectives development an advantage, but not essential.
- Excellent organisational and analytical skills.
- Ability to prioritise and manage multiple tasks.
- Excellent interpersonal, communication and presentation skills.
- Excellent knowledge of appropriate computer software such as MSOffice, Document Management Systems etc.
If you think you’ve got the skills and the attributes to join our ambitious, focused company, please send your CV, plus covering note to Susie at email@example.com.
Applications will be reviewed on an ongoing basis. Once sufficient suitable applications are received, the recruitment window will close.