Principal Clinical Data Manager
- Barnard Castle, County Durham (GBR), Stevenage, ENG (GBR), Stockley Park, Middlesex (GBR)
- £45 - £53 Per Hour
- 6 Months
- Start date: ASAP
- 2 positions available
- Ref: PCDM-TBC
- clinical studies
- protocol
- validation
- dataset
- data sources
- compliance
- risk management
- reporting
- monitoring
- project management
- management
- service level agreements
Principal Clinical Data Manager
Job Role
In this role you will be delivering the data management components of clinical studies, ensuring high quality data is available to the agreed timelines adhering to industry standard formats. You will have a keen eye for detail and a track record of successful delivery on high profile studies.
What will you do?
- 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.
- Provide 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 deliver a quality database in accordance with the Data Management Plan.
- Be accountable for defining the data capture tools for a clinical study.
- Develop and manages the execution of the validation and integration plan, including dataset definitions and external data sources. Manage vendor performance against Service Level Agreements.
- Be 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 monitos 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.
What do you need?
- Bachelor’s Degree or equivalent
- 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 GSK policies and SOPs
Ideally you will have
- Post Graduate Degree in Scientific Discipline
- Experience working with key global preferred suppliers/ partnerships to ensure deliverables are to the agreed standard.
- Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets.
Why Join GSK?
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
Thank you for your interest in this opportunity.
