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Clinical Data Manager, GDO (m, f, d)
Company:MSD International Business GmBH, Direct employer
Contact MSD International Business GmBH   |  Save this job  |  All job offers from this employer
 
Job description↓Employer profile↓
 
Publication date11.04.2020
Reference numberR43143
Field of activity
Other
Place of work***CH Suisse/ Schweiz/ Switzerland***, 8004 Zürich
Work experience requiredno
University degreeMaster
Long descriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are currently looking for a Team of Clinical Data Managers (CDMs) to be based in our new office in Zürich. (full-time, indefinite).

Under the direction of the applicable management, the Clinical Data Manager is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with our company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

• Receives the study related paper documents (i.e. patient diary, adjudication, etc.) from sites or other functional areas, registers them into a work management tool and transfers to data enterer for processing.
• Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.
• Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the SCDM/LCDM.
• Runs data integrity check reports in accordance with data review plans and relevant SOPs.
• Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
• Responsible for the execution of user acceptance testing of data management tools under the guidance of the SCDM/LCDM.
• Escalates overdue items, including but not limited to outstanding questions and missing visits.
• Assists the Senior/Lead CDM with data management activities to resolve all identified data issues prior to study database lock.
• Complete trial level archiving activities under the direction of the SCDM/LCDM including, but not limited to, filing of essential documentation.
• Maintains compliance with standard key performance indicators according to process expectations at the protocol level.
• Monitors data quality and cycle-time performance measures to maintain compliance, performs root cause analysis and implements action plans as needed.
• Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.


QUALIFICATIONS:

• B.A. or B.S. degree completed or currently enrolled, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
• Self-motivated, excellent in work planning and time management.
• Fluency in English (oral and written).
• Good sense and awareness of regulations and policies.
• Able to work under pressure and in a changing environment with flexibility.
• Good communication skills with the ability to communicate with both the technical and business areas.

Please apply here: https://jobs.msd.com/gb/en/job/R43143/Clinical-Data-Manager-GDO

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
Job advertisement (see PDF ->)Advert_Clinical Data Manager GDMS_P1_Final
 
  
 
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