Associate Director, Clinical Data Standards

Tarrytown, New York, US
Dec 06, 2018
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. Summary . Responsible and accountable for managing, directing and coordinating Clinical Data Collection Standards activities within DM Operations. Contributes to the strategy of Clinical Data Management group. Job Duties . Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports and ensures high quality performance for Data Collection Standards group . Establish a partner and customer-orientated Data Collection Standards . Leads and oversees all aspects of clinical data standards with a predominant focus on strategic and technical leadership, driving state-of-the-art/cutting edge data management and standards development . Responsible for the end-to-end data standards, metadata, governance and functional/technical excellence to enable efficient clinical da-ta/information across the full spectrum of development supporting decision making and regulatory submissions while ensuring state of the art interoperability of systems support-ing development processes . Drives the vision for clinical data standards to effectively support Regeneron's clinical research strategy, from collection through submission . Collaborates closely with Global Development functions, to ensure that data collection standards packages are defined, measured, managed and used to improve efficiency and qual-ity of clinical trial collection, analysis, reporting and submission . Represents Data Management on the Data Standards Committee DSC to ensure core standards needs of the department are met . Leads the BDM data governance process to ensure consistent data standardization is enforced across Global Development . verall accountability for the functioning of the Data Standards . Functionally manages staff supporting the development of new Regeneron data collection standards . Initiates and leads business process changes in the context of data standardization as well as required capabilities to support standards education new terminology, approach, and context and training data standards implementation, CDISC - ODM, SDTM, ADAM . Works with external organizations to develop best practices and advance clinical data standards . Participates as a recognized Regeneron leader to selected external data standards working groups within HL7, CDISC, and ICH . Provides input to and undertake the implementation and maintenance of global working practices and standards . Contributes to the development of the Clinical Data Management organization through his/her leadership role on the management team . Represents Clinical Data Collection Standards at cross-functional forums, meetings and provide timely feedback to partners . Leads and supports clinical & non-clinical special projects . Supports the establishment of training programs technical and professional skills for Clinical Data Management staff and ensure staff training is conducted and properly documented . If required, deputizes for the responsibilities of the Operational/Functional Manager . Participates in Health Authority inspections as required . Ensures that each associate has an up to date training and development plan in place . Where appropriate, ensures a mentor is assigned including managers . Ensures adequate resources are in place . Reports to Director if there are any additional unanticipated demand for resources Adheres to procedures surrounding retention of data, records, and information for clinical studies May provide Subject Matter Expert Support for select topics assigned #LI-LR1, LMR, Clinical Data Standards, Clinical Data Associate Director, Clinical Data . Requirements . Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 5 or more years of clinical data integration into EDC experience and 10 or more years experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus. May be required to manage up to 3+ direct reports. Self directed and comfortable working in cross-functional teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required. Familiarity with all applicable regulations including . CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required. Ideally 10 or more years' experience in clinical data standards with at least 8 years in Clinical Data Man-agement. Must have direct, demonstrated excellent proficiency with CDISC, CDASH, STDM and related industry standards. Proficiency with Medidata Rave a plus. Additionally, Microsoft Office applications. Software proficiency with CDMS required. May manage up to 3+ direct reports and in a matrix environment. Strong coaching and training skills - team player. May report to Director or above. This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business. To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. LMR, Associate Director/Sr Mgr, Strategic Planning and Data Operations, #LI-LR1