Assoc Manager Clinical Study (General Medicine) - Tarrytown

Employment Type

: Full-Time

Industry

: Healthcare - Allied Health



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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 Senior Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior 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. Responsible for direct line management responsibilities.

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 Leader (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

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

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

Requirements:

Bachelor's degree and minimum of 8 years relevant industry experience. advanced degrees may be considered in lieu of relevant experience.

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

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.
Associated topics: biomedical, dietician, disease, food, healthcare, immuno oncology, microbiology, pharmaceutical, physiologist, physiology

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