Clinical Data & Technology Manager
ProClinical is partnering with a leading global pharmaceutical company that specialises in multiple therapy areas. This organisation is currently looking to recruit a Clinical Data & Technology Manager to join their office in Massachusetts. This is an exciting opportunity to join a leading worldwide company with a strong reputation as an outstanding company to work for.
The Clinical Data & Technology Manager will manage all aspects of the clinical trial data management process from study start up to database lock for trials conducted through an outsourced partner / Contract Resource Organization (CRO).
- Acting as the data expert and representing as CDMT on study team as applicable.
- Working with the CRO to ensure data collection tools capture protocol requirements.
- Identifying and resolving data flow process issues in collaboration with the project team.
- Defining data handling conventions, quality acceptance, and auditing criteria for data collection and data deliverables.
- Providing guidance and sponsor approval per CRO SOPs and process exceptions.
- Serving as an internal CDMT expert for client cross functional team members.
- Liaising with third-party vendors in support of study team escalations.
- Monitoring timelines to ensure that data management-related deadlines or contributions to study deliverables are proactively defined and met.
Skills and Requirements:
- BS/RN/MS/RPH degree in health-related field preferred.
- At least 5 years of clinical data management experience in the pharmaceutical/biotechnology industry.
- Knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management.
- Strong comprehensive understanding of CDISC (SDTM), clinical experience in the oncology, neuroscience, or gastrointestinal preferred.
- EDC and coding experience with WHO Drug and MedDRA desirable.
- Strong knowledge of SOPs, GCP standards, and CDM systems.
- Strong communication skills to internal and external audiences.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in 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 Kevin Cassini at +1 215 531 5288 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.
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