Principal Clinical Data Manager - niche
An attractive job opportunity has arisen at a leading multinational pharmaceutical company who is seeking a Principal Clinical Data Manager to work at their UK site. The company employs 100,000 personnel across 150 countries, working across multiple therapy areas including cardiovascular, oncology, and respiratory.
- Delivering the data management components of clinical studies.
- Ensuring high quality data is available to the agreed timelines adhering to industry standard formats.
- Keen eye for detail and a tracking record of successful delivery on high profile studies.
- Global study level contribution as Data Manager or in close collaboration with the Project or Study Data Manager and other members of the study team.
- Point of contact for complex data management and data quality considerations.
- Providing input to protocol development and other key documents e.g. Monitoring Plan, Protocol Deviation Management Plan, Reporting & Analysis Plan and Data Management, Plan Manage in-stream data flow activities and delivering a quality database in accordance with the Data Management Plan.
- Defining the data capture tools for a clinical study.
- Developing and managing the execution of the validation and integration plan, including dataset definitions and external data sources.
- Managing vendor performance against Service Level Agreements.
- Responsible for the set-up and maintenance of the trial master file (TMF) and DM TMF artefacts throughout the study life cycle.
- Input into oversight plans and manage oversight of CRO, off shore partners and other Third Party Resources.
- Train monitors and site staff on use of data collection tools and query management process.
- Subject Matter Expert for the Data Management Community in a specified area(s) of functional expertise.
Skills and Requirements:
- Bachelor's degree or equivalent.
- Post Graduate Degree in Scientific Discipline
- Experience working with key global preferred suppliers/ partnerships to ensure deliverables are to the agreed standard.
- Clinical trial experience.
- Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
- Understanding of the tools of the trade, such as standards.
- End-to-end global medicine development experience.
- Pharma, CRO and/or ARO experience.
- Understanding of disease area.
- Understanding of laboratory data.
- Understanding of CDISC
- Understanding of applicable ICH/GCP regulations and applicable the company's policies and SOPs.
- Demonstrates the discipline of project management to plan, organise and manage activities to deliver specific study goals and objectives to measurable targets.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.