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Position SummaryThe Associate Director, External Data Strategy drives the management of source patient sample data originating from or delivered to external vendors or transferred between vendors. The position develops governance and operational oversight standards for the conduct of data exchange for study-specific data transfers and data repositories. The position manages the development of data transfer agreements and specifications, coordination of external data reconciliation, and the quality review of imported and external vendor data. Activities used in the management and overseeing of external vendors are performed to ensure complete, accurate, high quality, regulatory compliant data and seamless transfer of data. Activities are performed according to external regulatory requirements, and internal standard operating procedures (SOPs), accepted industry best practices and established project deadlines. The position assists in the implementation of the corporate strategic plan in the GCDM department with the adoption of future technologies. Principal Responsibilities
Develop governance and oversight for the processes related to data exchanges between external vendors (e.g., laboratory data (local and central), PK/PD data, assay samples, ECG, imaging, etc.).
Provide oversight for external data management activities in-house or in partnership with CROs.
Support a rollout strategy for implementation of new processes, standards, and/or technologies to ensure clear scope, comprehensive communication, training, assessment, and continued improvement opportunities for internal personnel and outsourced provider(s).
Develop template database specifications in support of the Data Standards, Integration and Innovation team; and data transfer agreements with data specifications in support of the Clinical and Statistical Programming team; for data provided by or to external vendors and/or review specifications provided by external vendors
Act as subject matter expert for data transfer requirements for Alexion.
Participate in data integrity discussions and strategy planning including the mapping of external data flows and the provision of inspection ready documentation
Provide guidance to study teams and internal stakeholders on the process and timelines for study data import/export associated with external vendor data.
Qualifications
Minimum 8 years of experience in Pharmaceutical or Biotech laboratory data review and processing in Clinical Data Management (CDM)
Proficient on medical tests, specimens, methods, and standard results.
Proficient to define, standardize external source data including test names, specimens, method, and units to CDISC NCI controlled terminology.
Proficient to review external data for medical sensibility and logic.
Proficient on scientific and technical knowledge of external data processing for clinical trials and how they apply to review of clinical data.
Possess a thorough knowledge of medical terminology and the clinical data management and the clinical trial process.
Experience with regulatory requirements and the submission process.
Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company.
Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
Education
Requires a Bachelor’s degree in a scientific discipline, information technology discipline or equivalent.
LI-KD1[[filter5]], [[filter1]][[filter4]]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.
