A Senior Clinical Data Manager (SCDM) has a keen attention for detail and is responsible for providing leadership or support for the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. SCDMs will provide leadership or support for multiple, high volume and extremely complex studies within a development program. The individual will perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions.
- Serve as lead CDM or assist the lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings.
- Responsible for providing support for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope.
- Responsible for the accurate development of CRFs, data entry screen development, and edit specifications per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials.
- Perform pre-, during, and post-data entry review of clinical data; identify data discrepancies and corresponding resolutions, and generate and manage queries on assigned clinical trials.
- Develop, document, maintain and finalize the data management plan (DMP).
- Provide ongoing operational support for Medidata RAVE activities during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications.
- Provide ad-hoc report development, and support database lock and archiving activities.
- Review and contribute as a member of the CRF development team to develop the data collection modules on assigned studies where protocol requirements are outside of standard CRF library versions.
- Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
- Participate in the development of standard operating procedures (SOPs).
- Mentor junior staff on clinical data management activities and procedures.
- Provide guidance to clinical data management personnel on assigned projects, reviewing study documents as needed, e.g. Data Management Plan, Operational Plan for database locks
- Ensure project documentation is being archived in a timely manner into the Trial Master File.
- Independently monitor own activities and project status for successful project deliverables according to timelines.
- May lead or participate in initiatives to streamline data management processes.
- Experience in clinical data management for 5+years.
- Experience in vendor management of outsourced studies
- Demonstrate strong medical terminology skills.
- Experience defining, entering, processing, reviewing and validating clinical data; and understanding and following clinical trial protocols and data collection documents.
- Medidata Rave experience required.
- Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
- Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding preferred.
- Possess effective written and verbal communication skills, interact professionally with personnel at all levels within and external to the company, and be dependable and a team player.
- Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be capable of working under deadlines.
- Capable of working on multiple projects simultaneously, independently manage responsibilities according to deadlines, and define tracking tools to manage projects.
- Experience in solving extremely complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements.
- Possess a thorough knowledge of Data Management SOPs and regulatory requirements, and be capable of providing guidance to and training peers.
- Requires a Bachelor’s degree in a scientific discipline or equivalent.
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.