Director Clinical Data Management
This is a very exciting time for a Director Clinical Data Manager to join this pharmaceutical organisation as they continue to leverage their considerable expertise in the delivery of clinical trials. This company posses a unique combination of operational excellence and the latest technology, helping to reduce the costs and increase the speed of developing new medicines. The talented Director Clinical Data Manager will provide leadership for clinical data management tasks and be responsible for the delivery of multiple, large or complex projects.
- Lead/support the development of CDM-owned and CRO Operations-wide improvements
- Lead/support the selection and implementation of CDM and CRO Operations systems
- Contribute to the development and delivery of KPIs and relevant metrics
- Act as expert in the business on behalf of CDM/CRO Operations and provide senior consultation within CDM and/or to clients
- Support business development activities and contribute to the development and growth of business opportunities
- Lead/contribute to the development of proposals and associated costings; input into standard cost models; prepare and attend bid defences; and contribute to the development of marketing materials
Skills and Requirements
- Degree level qualification or equivalent experience with in-depth experience in the discipline of Clinical Data Management
- Extensive knowledge of database design, structures and the handling of data from external sources
- Extensive experience of leading EDC and/or eSource studies
- In-depth knowledge of the clinical trial process and systems applications to support operations
- Thorough knowledge of time and cost estimate development and service pricing strategies
- Thorough knowledge of ICH guidelines and GCP including regional regulatory requirements for the conduct of clinical development programs.
- Working knowledge of the relationship and regulator obligation of the CRO industry with pharmaceutical biotechnological companies
- Excellent oral and written communication and presentation skills
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.