Clinical Data Manager
Proclinical is currently recruiting for a Clinical Data Manager for a pharmaceutical company located in Collegeville, PA. Successful candidate will deliver the data management components of clinical studies, ensuring high quality data is available to the agreed timeline.
- 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 manage 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, offshore 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.
- 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
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 call Sarah Beshara at (+1) 267-477-3355 or upload your resume 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.
Proclinical Staffing is an equal opportunity employer.