Senior Data Standards and Governance Manager (m/f)

Vertrag | Darmstadt, HESSEN | 8 Monate | Frist: Samstag, 06. Oktober 2018, 00:00 Uhr
Diese Position ist abgelaufen. Nicht bewerben!


Excellent & Comprehensive;...


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Job 396 of 1000
Senior Data Standards and Governance Manager (m/f)

Company: Docs Global (Continental Europe)
Location: Darmstadt,Germany
Reference: Ref AS-026587
Closing Date: 06 Oct 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

For one of the Top 4 global players in the pharmaceutical industry DOCS is hiring a Senior Data Standards and Governance Manager (m/f). The scope of this role is project leadership in the area of Global Clinical Data Sciences:


Roles & Responsibilities of the position

• Supervise surveillance of CRO activities regarding the quality and timeliness of the deliverables.
• Ensure quality, harmonization, and maintenance of industry and internally-defined clinical data standards in the metadata management library.
• Participates in cross-functional teams to coordinate data standardization across Data Collection and SDTM.
• Develop and maintain training modules on standards implementation; educates others on metadata vocabularies and the importance of standardization.

Job Requirements

The successful candidate has at least 8-10 years’ experience in both CDISC, CDASH and SDTM. With a solid understanding of how to design Standard Case Report Forms (eCRFs) used for the collection of data in clinical trials. This should include:
• Advanced degree in Life Sciences, Mathematics or Computer Sciences.
• Solid experience and knowledge of CDASH 2.0 and worked extensively in CDASH-based data collection standards.
• Very good understanding of current CDISC SDTM Implementation guide version 3.2 / SDTM Model Version 1.4.
• Solid Experience in drafting CRF Metadata structure for standardizations and mapping to SDTM domains.
• Solid experience in metadata curation and governance activities in collaboration with functional area representatives (biostats, SDTM experts, clinical trial mgmt.) and domain experts during Core and Therapeutic Area metadata standards development, deployment and maintenance activities.
• Solid knowledge of NCI Controlled Terminology and the impact on CDASH, SDTM.
• Good knowledge in external standards development.
• Excellent communication skills and able to work both within a team and independently.
• Fluent English

Remuneration & other details

- Permanent contract with DOCS
- Full time, office based in Frankfurt/Main area. Home office options can be discussed.
- Great pipeline of studies -> very good long term perspective.
- Top 4 global player in the pharmaceutical industry.
Why this vacancy is right for you:
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.
Interested? Please submit your CV to or call me on +49 (0) 89 666 105 162. We are looking forward to your application.

Contact Information:
Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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