Clinical Data Manager
Paul De Challans is recruiting for a Clinical Data Manager to join a company in the pharmaceutical industry at their site based in London on a contract basis.
The main purpose of the role will be to:
The CDM will lead all data management activities within one or more clinical studies or project(s) working closely with other drug development colleagues, medical officers and CRO's/contractors, under the guidance of the Manager, Clinical Data Management (and Head of Data & Regulatory Sciences, where appropriate) to ensure the quality and integrity of the data is maintained whilst identifying, and minimising where possible, risks to the project(s).
- Conduct oneself at all times in accordance with Quality Management System, working practices and Good Clinical Practice regulations, and ensure training in these areas is kept up-to-date at all times.
- Be responsible and accountable for all appropriate data management aspects of a clinical study.
- Be the primary contact for all data management activities of the study(s).
- Be the primary contact for external consultants and Service Providers for all appropriate data management activities of the study(s).
- Contribute to the setting up, implementation and reporting of clinical study(s) within all appropriate data management aspects of the study(s) as the data management lead for the study(s).
These responsibilities shall include but are not limited to;
- Being responsible for developing and maintaining study documents within all appropriate data management aspects of the study(s), e.g., including but not limited to, data management plan, (e)CRFs, data transfer specifications, (e)CRF guidelines and edit check specifications.
- Providing input to study documents, e.g., a project plan, study protocol, statistical analysis plan, operational documents, clinical study report, and/or authoring relevant sections of study documents.
- Reviewing and providing guidance on clinical science queries, to ensure appropriateness of queries and query language
- Managing SPs/contractors and overseeing their performances and quality of work to ensure they meet an agreed project plan, contracts and any study specific requirements within all appropriate data management aspects of the study(s).
- Ensuring learning and knowledge transfer during and at the completion of the study/project.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A BSc or BA degree in Life Sciences
- Significant demonstrable experience of Data Management in early phase development in the EU/US.
- Ability to oversee and manage CROs throughout the entire life-cycle of a study (database set-up through to database lock). Excellent communication skills (verbal and written), organisation, presentation and time management skills
- A clear understanding of the principles of ICH-GCP, GMP and regulatory requirements in both EU and US.
- Proven ability for working independently with minimal supervision. A can-do attitude with a willingness to get actively involved.
- Must be diplomatic and tactful in liaising with staff and management.
- Must be meticulous and methodical, with the ability to review both data and procedures in detail and the ability to see the greater overall picture.
- Excellent IT Skills (PCs, Windows and Microsoft Office).
- Experience working in a team environment under time and resource pressures.
- Strong experience working with EDC systems (e.g., Oracle Clinical, Medidata RAVE). Previous exposure to SAS would be an advantage
This is an excellent opportunity to join a global pharmaceutical company.
For more information or to apply for this position, please contact Paul De Challans on 01246 45 77 33 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30536 in all correspondence.