Senior Clinical Data Manager

, United States
12 Feb 2019
14 Mar 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Senior Clinical Data Manager - Office based Boston (FTC 6 months)

Clintec is actively recruiting for a Senior Clinical Data Managerto join our expanding global company in Boston, USA. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. Position:

Clintec is looking for an experienced Senior Clinical Data Manager to join our team in our Boston, Massachusetts offices. Reporting to the Senior Director, Data Management, the successful candidate will provide data management leadership and expertise in the implementation and execution of data management activities for clinical study programs (phase I-III) while ensuring the timely completion of deliverables in accordance with timelines and budgets. The Senior Clinical Data Manager (Contractor) must have experience managing and providing oversight of data management activities for clinical studies (Phase 1-3) outsourced to third party vendors (CROs, central labs, specialty labs, IXRS, etc.) from study start up activities (including feasibility) through close-out. This individual must be an experienced Data Manager who is able to work independently and cross functionally.

Responsibilities: • Manage and lead the day-to-day operations of assigned study to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements • Contribute to the decision-making process involving data management issues for Phase 1-Phase 3 studies • Provide input into the presentations that involve relevant data management topics; perform data related trainings and/or oversee training presentations delivered by service providers relative to data collection • Work on/lead cross-functional teams and lead outsourced vendors to produce high quality data, develop timelines and review budgets and contracts to ensure departmental and corporate clinical trial data management objectives are met • Oversee service providers to perform core data management functions including IWR/IVRS, CRF, edit check and CRF completion guidelines development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures • Ensure clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission by working with lead CRO data manager or equivalent • Coordinate and participate in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy • Ensure all clinical data (within EDC and external data sources) is of a quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock • Maintain the study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial • Develop/utilize study metrics to monitor quality, project status, activities and budget and work with Manager to identify trends and provide updates/recommendations on opportunities for improvements

Skills and Experience

• BA/BS degree • Requires at least 5-10 years of experience in data management with 3 or more years as a Lead Data Manager for a Ph2 and/or Ph3 study; experience working within a small biotech environment is a plus. • Experience in managing data management activities, from study start up to close out, on one or more clinical studies (Phase I-III). • Experience with an electronic data capture data management system (e.g., Rave) and external data structures (e.g. IxRS, ePRO/eCOA) • Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries • Understanding of ICH GCP as well as general knowledge of industry practices and standards (CDISC, SDTM, CDASH) • Demonstrated experience in working with and negotiating with Clinical Research Organizations (CROs) for data management. • Ensures adherence to standard operating procedures and FDA regulations with strong understanding of inspection readiness. • Productivity/Organizing/Planning - Must be proactive and self-disciplined and meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. • Demonstrated ability to work independently with exceptional organization and attention to detail. • Excellent oral and written communication and presentation skills.

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.

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