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.
The Clinical Study Lead (CSL) is accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. The CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. 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. Contributes and drives ongoing process improvement initiatives. May have direct line management responsibilities.
- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
- Provides operational input into protocol development
- Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
- Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
- Ensures compliance with the clinical trial registry requirements
- Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
- Provides input into baseline budget development and management
- Provides input into baseline timeline development and management
- Leads risk assessment and identifies risk mitigation strategies at the study level
- Leads the feasibility assessment to select relevant regions and countries for the study
- Oversees/conducts site evaluation and selection
- Leads investigator meeting preparation and execution
- Monitors progress for site activation and monitoring visits and acts on any deviations from plan
- Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
- Monitors data entry and query resolution and acts on any deviations from agreed metrics
- Ensures accurate budget management and scope changes for internal and external studies
- Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
- Escalates issues related to study conduct, quality, timelines or budget to Program Operations Lead (POL) and other stakeholders and develops and implements appropriate actions to address issues
- Oversees the execution of the clinical study against planned timelines, deliverables and budget
- Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
- Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
- Ensure clinical project audit and inspection readiness through the study lifecycle
- Supports internal audit and external inspection activities and contributes to CAPAs as required
- Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
- Contributes to clinical study report writing and review
- Facilitates and contributes to study level lessons learned
- Assigns tasks to Clinical Study Management staff and supports their deliverables
- Recommends and participates in cross-functional and departmental process improvement initiatives
- Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
- Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight
- May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
Key Team Membership (including, but not limited to):
- Demonstrated interpersonal & leadership skills
- Ability to understand and implement the strategic direction and guidance for respective clinical studies
- A data driven approach to planning, executing, and problem solving
- Effective communication skills via verbal, written and presentation abilities
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Ability to influence and negotiate
- Budget management experience
- An awareness of relevant industry trends
- Ability to build productive teams and collaborations
- Demonstrated vendor management experience
- Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
- Experience in global clinical trial operations including experience developing protocols and key study documents
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Effective project management skills, cross-functional team leadership and organizational skills
- Line management experience preferred
Cross Functional Interfaces (including, but not limited to):
- Clinical Study Team
- Clinical Operations Review Meeting(s)
- Clinical Compliance Meeting(s)
- Project Management
- Data Management, Biostatistics
- Medical Director(s)
- Clinical Finance
Bachelors degree and minimum of 6 years relevant industry experience; advanced degrees may be considered in lieu of relevant experience.
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 Regenerons 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.
An important note about privacy:
Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media. We do not interview candidates on Google Hangouts. Any questions about job listings can be directed to email@example.com. We also do not hire for "at-home data entry" positions.