Senior Manager, Data Management External Clinical Data Integration

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:
Leads and manages the Oncology DM Operations - External Clinical Data Integration team. Manage, assign resources, direct and coordinate the external data transfer specifications development and ongoing data transfers, implementation of eCOA/ePRO and other external clinical data collection methods based on the level of TA requests, to ensure that all data management deliverables are developed to a consistent high standard with respect to quality and timelines

Job Duties:
Select, recruit, develop, manage, motivate, coach and assess performance of direct re-ports including high quality performance management across the group.

• Globally accountable for the external data acquisition (central labs, biomarkers, ECGs, imaging etc.) management activities across all NVS Oncology portfolio in line with the clinical trials' expectations.

• Leads the External Data team from data transfer specifications through implementation of external data flow into production.

• Develops and maintain a patient-centric and cost-effective ePRO adoption strategy for NVS oncology in alignment with the DM Operations strategic vision and direction and trends in the electronic mobile data collection methods.

• Oversees the end-to-end electronic Patient Reported Outcome (ePRO) development and implementation processes (Plan-Design-Develop-Implement-Maintain) and leads the pro-cess re-engineering effort to establish/transform and significantly improve the cycle time and quality of the deliverables.

• Oversees the external vendors' performance as it relates to the external data and ePRO deliverables and ensure that these deliverables are on time and of high quality.

• Track and assign appropriate resources in line with Company priorities in order to meet timelines for external data deliverables.

• Propose and lead development of new SOPs and working practices where appropriate, provide input to and undertake the implementation and maintenance of such documents and standards.

• Interface with internal and external business partners (e.g. 3rd party vendors, Data Man-agers, Standards, Database Development teams, Health Outcome Research) in order to improve external data processes and patient data capture systems.

• Represent as the ePRO business process owner and expert on the departmental and cross-functional projects and assignments that help gain speed, increase efficiency and raise the quality of deliverables.

• Lead, support or provide mentoring to staff members involved with special projects both clinical and non-clinical in nature.

• Establish training programs (technical and professional skills) for staff and ensure staff training is conducted and properly documented.
Adheres to procedures surrounding retention of data, records, and information for clinical studies
May provide Subject Matter Expert Support for select topics assigned

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 8 or more years experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus.
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.
o Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project mgmt skills. Strong written and oral communication skills required.
Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with Medidata Rave Coder a plus.
May manage up to 8-10 reports 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.

#LI-JH1