Clinical Data Manager
Posted on Mar 15, 2019 by Clintec
Clintec is actively recruiting for a Clinical Data Manage rto join our expanding global company in france this is an office based opportunity. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. Role Description The Clinical Data Manager is responsible for the day-to-day operational data cleaning activities and general administrative tasks involved in clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity is coordinated in conjunction with one or more vendors and, where appropriate, Clinical Operations staff. Responsibilties of the Clinical Data Manager • Work independently on most activities on studies at different points (start-up, conduct, close-out). • Conduct discrepancy management activities of studies assigned to them. • Conduct third party vendor and SAE reconciliation and flag discrepancies. • Assist the Senior Data Manager in creation of study start up documents like eCRF, Data Management Plan, Data Validation Plan, eCRF completion guidelines etc. • Complete data entry tasks into the CDMS as applicable • Assist with medical coding if applicable and database lock preparation for the assigned studies • Assist Senior Data Manager in attending study meetings and meetings with relevant stakeholders as applicable • Conduct User Acceptance Testing activities e.g. Create test plan, test scripts, Data Base testing etc. General Administration • Upload/File documents in the eTMF/TMF as per the SOPs. • Update the study tracker, metric reports and any other trackers as requested by LM. • Carry out all general study filing activities with appropriate quality. Training & Compliance: • Mentor Clinical Data Assistants/Interns for DM activities • Responsible to undergo training on study protocols and ensure that data cleaning is performed to the highest standard • Ensure all data cleaning activities are compliant with Standard Operating Procedures (SOPs) and ICH-GCP guidelines. • Ensure compliance to trainings as per the training plan approved by the LM Supervisory Responsibilities • No immediate line management responsibility Education: • Combination of education and experience
• Understand Clinical Trial Process - Clinical Trial lifecycle - Protocol to Database delivery. - Clinical Database Development / Specifications. - Understanding of project timelines. - Clinical Data Management tools and processes - Develop & QC Reports (either standard or study-specific) Experience: • Typically requires related experience and/or combination of education/training. Knowledge of CDMS systems such as RAVE with study set up and database lock experience would be preferred, however, training will be provided. Knowledge/Skills/Abilities: • A good technical ability desirable. • Strong grasp of basic Microsoft tools (word/excel/outlook etc) is required. • Critical thinking and attention to detail. • Ability to follow instruction, may be required to complete regular assessment before being able to perform Performs job duties with minimal guidance from the Manager or peers • Demonstrates good judgment in selecting methods and techniques for obtaining solutions • Networks with internal and external personnel in area of expertise. Company Information: Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology. Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.