Senior Clinical Data Manager

Typ práce: hlavní pracovní poměr

Our client, a well-established, strong and respected international biotech company, is looking for a Senior Clinical Data Manager due to company´s further expansion. Become an important part of fulfilling the strategy of our client to establish itself as an original biotech/pharmaceutical firm with global presence.

The main purpose of this position is to provide expertise in all data management activities related to the preparation and implementation of clinical trials all around the world while working closely with colleagues from relevant departments whose activities support database development and reporting for all clinical studies.

To be able to do so, you shall:

• oversight/management (of CRO's) and participate in study set-up and initiation procedures such as eCRF design, database design, edit check design/review, and DMP (data management plan) review.
• proper collection, management, and storage of clinical trial data (according to regulatory requirements) + their review and query management.
• development of data management guidelines and quality processes to ensure final databases are accurate
• Specify / perform data validation and quality checks, and initiates corrective and preventive actions as indicated.
• Specify / run standard and custom reports (in Medidata Rave or other EDC systems) to support Clinical Operations and Development.
• Manage development and implementation of company data standards; ensure implementation of CDISC-SDTM as appropriate
• Manage and coordinate vendors with regard to data management tasks, ensure timely delivery of agreed items.
• Participate in other activities and meetings to support Biostatistics, Clinical Operations, and the Development Team as needed.
• Perform these tasks with a high level of independence and proactivity.

Qualification needed:

Bachelor's degree in medical, scientific, biological, statistical, computer science, or related field (higher is much preferred)

• 5 years+ of clinical trial data management in the pharma/biotech industry incl. Phase 3 (NDA submission)
• Data management experience using Medidata Rave EDC system / INFORM / Other EDC systems, reporting capabilities.
• Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications.
• Strong vendor management skills, creativity, ability to identify a need for new processes.
• Fluent English

What do we offer:

• Rapidly changing environment where you could use your potential, proactive and autonomous personality with a good capacity to determine work priorities
• Challenging and responsible position within a well-respected field
• International working experience
• Opportunity for constant personal and professional growth
• Starting date upon agreement

If interested, please provide us with your structured CV.

Kontaktní osoba:
Barbora Blažková

E-mail:
barbora.blazkova@talentor.cz

Vloženo: 26.1.2014