Manager, Clinical Document Management, Site Start Up

Location
Tarrytown, New York
Posted
Mar 20, 2018
Ref
11599BR
Required Education
Masters Degree/MBA
Position Type
Full time
Position Summary

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:

The Manager, Clinical Document Management, Site Start Up serves as the primary contact for the coordination and review of essential documents required for release of Investigational Product on site for the conduct of a clinical trial. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. May have direct line management responsibilities.

Responsibilities:

Essential Document Review/Approval
  • Establishes and maintains standard requirements for site start up essential documentation.
  • Manages and oversees site start up essential document review/collection for one or more programs and one or more trials in both in-sourced and fully outsource models
  • Prepares and provides Essential document package to sites for insourced studies (e.g., Phase 1 studies). Colloborates directly with sites in regards to collection of documents and IRB timelines for site activation.
  • Oversight of the CRO in relation to clinical study documents filed in the Trial Master File (TMF) from the development of the filing structure (study start-up) in compliance with SOPs and guidances.
  • Ensures documents are provided to Regulatory Affair within established timelines, escalates risk when appropriate
  • Collects, reviews and tracks study documents required for site activation and Investigation Product release according to relevant SOP's and regulations
  • Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to Regeneron standards Department Performance, Metrics and Systems
  • Manage and maintains the Site Start Up metrics and dashboard and provides updates to management, as needed
  • Continuous improvement activities for dashboard functionality, including particpation in system UAT testing, etc.
  • Develop Standard Operating Procedures and Working Documents to document and communicate processes and procedures Oversight
  • Provides and trains CROs on Regeneron essential documentation site startup expectations.
  • Provides metrics to CRO in regards to outstanding documents identified during regulatory document review
  • Particpates in CRO Partnership level document review
  • Colloborates with Reg Affairs and Compliance as needed to address concerns
  • Supports Clinical Study team in ensuring regulatory documents are submission and audit ready
  • Colloborate with vendors as needed regarding system requirements and functionality
  • Supports internal audit and external inspection activities and contributes to CAPAs as required Study Team Interaction
  • Represents Site Start up on cross-functional study team (s) and/or sub-team(s); Attends Kick Off meetings to present SSU Roles and Responsibilities
  • Partipates in obtaining clinical trial insurance for studies/sites
  • Attends clinical study team meetings to keep abreast of study timlines
  • Colloborates with CRO to ensure efficiency and resolution on document issues
  • Reports on status of Regulatory Document review in relation to site activation Staff Management
  • Line management responsibilities may include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
  • Mentors, trains, and onboards junior staff Process Initiatives
  • Recommends and participates in cross-functional and departmental process improvement initiatives
  • Performs other tasks as required and directed by department management

Requirements:

Minimum Years of Experience:
Bachelor's degree with at least 6 years of relevant/clinical essential document review experience or equivalent experience.
  • Solid understanding / knowledge of the clinical drug development process and clinical trial methodology;
  • Knowledge of ICH/GCP and regulatory guidelines/directives;
  • Disease/therapeutic area knowledge (a plus);
  • Ability to effectively multi-task and prioritize in a fast paced environment;
  • Effective problem solving skills;
  • Strong attention to detail and organization skills;
  • Technical proficiency in eTMF and MS applications including (but not limited to) PowerPoint, Word
  • Good communication and interpersonal skills;
  • Ability to work in a matrix environment
  • Prior experience with obtaining and applying Clinical Trial insurance
  • Strong ability to prioritize and drive for results
  • Strong and disciplined project management skills
  • Ability to effectively work across the organization and with outside vendors
  • The ability to influence decision making and tactfully push-back
  • Good team player with a positive attitude

Key Team Membership (including, but not limited to):

• Clinical Study Team
• CRO Governance Committees (eg. Joint Oversight Committee) as needed

Cross Functional Interfaces (including, but not limited to):

• Clinical Trial Management
• Regulatory Affairs
• Corporate Counsel, Legal
• Risk Management, Treasury
• Vendor & Relationship Mangement

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.

Requisition Number: 11599BR