Senior Data Manager

Job description & responsibilities

Ø In charge of all aspects of the data management process from the definition and design of CRF and database to the release of a clean database for statistical analysis.
Ø Communication with the sponsor and other interlocutors of the project regarding data management issues.
Ø Training and coaching of data manager assistant and data entry personnel.

Key responsibilities
Ø CRF design and review ascertaining the data collection requirements of the study through review of the protocol and other supporting documentation.
Ø Create the data management plan.
Ø Create the annotated CRF, develop or validate project specific clinical databases with appropriate software.
Ø Create the data validation plan including edit-checks and listings.
Ø Coordinate all data cleaning activities including DCF/query handling and coding management.
Ø Coordinate handling of external data transfer, integration and reconciliation with the study database.
Ø Perform/coordinate database lock activities in close collaboration with sponsor, statistician and other parties.
Ø Development of study specific operating procedures if required.
Ø Production and maintenance of the appropriate documentation for all steps in the data management process according to SOPs.
Ø Perform tasks in accordance with IDDI standard operating procedures.
Ø Assist in development and update of SOPs.


Your Profile

Education & Training
Ø University degree in health related field or computer science or equivalent experience. Other required courses: not applicable.
Experience & Key competencies
Ø Experience in clinical data management.
Ø Advanced database management skills.
Ø Experience in working within the clinical trials environment.
Ø Experience in SAS programming.

Ø Good interpersonal skills (communication, organizational and time management skills).
Ø Accuracy and looking at details.
Ø Ability to work in team environment.
Ø Knowledge of Good Clinical Practice and regulations governing clinical trials and electronic data.
Ø Thorough knowledge of dictionaries/coding process.
Ø Working knowledge in English.

Demba Sidibe | Stamford Consultants AG
Recruitment Consultant | Recruitment Redefined
Tel: +41 61 560 77 28 | Mob: +41 76 276 16 05
Friedensgasse 10, 4143 Dornach (SO)
[Email hidden]
www.stamford-consultants.com

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