The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. We are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, we are committing to innovation in order to treat unmet medical needs and bring value-adding products to markets. Grünenthal is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients.
Post : Clinical Data Manager (m/f) (23621)
Responsibilities:
- Implementation of Data management activities within assigned clinical trials
- Providing input into the selection and qualification of third party vendors
- Manage Data Management CRO and external providers in preparing, conducting and closing of data management activities (e.g. design of Case Report Forms (eCRFs), patient diaries (ePRO), Data Management Plan, database structure and consistency check specifications, data review, SAE reconciliation, coding, database lock)
- Define (quality) requirements for activities performed by Data Management CRO's or external data providers (e.g. for ePRO data, laboratory data) and provide adequate sponsor oversight
- Monitoring and supervision of the set-up and maintenance of CDMS systems and eTools such as EDC & ePRO
- Creation and execution of data quality checks and centralized monitoring checks
- Filing and archiving of trial documentation
- Ensuring that all functional activities are performed to meet the defined timelines, budget and quality specifications
- Ensuring compliance according to GCP-ICH and other relevant guidelines
- Support of the creation, review and approval of procedural documents for the Clinical Data Management area
- Contribution to the further development of the Data Management department
Candidate Profile :
Bachelor’s degree or diploma in data sciences, natural sciences, informatics or equivalent degree
Proficiency and profound experience in all relevant clinical data management activities in the pharmaceutical industry or CRO industry
Experience in leading CDM activities on trial level and managing and supervising external CROs / vendors
Experienced user of CDMS systems and eTools like EDC (Medidata Rave) and ePRO
Strong understanding of data and database structures (CDISC SDTM)
Experience in working with SAS and J-Review
Proven ability to work in cross functional teams
Being familiar with all relevant guidelines and aspects of clinical data management
Pro-active and self-motivated personality and flexible but persistent and result-oriented
Excellent communication skills
Proficient verbal and written skills in English
Additional info:
Qualification: B.Pharm
Location: Germany - Aachen
Area: Research & Development
Requisition Number: 23621
Apply Online : Click here
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