Senior Clinical Study Lead - (Oncology)

Location
Tarrytown, New York
Salary
Competitive salary and benefits
Posted
May 17, 2018
Closes
Jul 14, 2018
Ref
13056BR
Education
BS
Hours
Full Time

Senior Clinical Study Lead - (Oncology)

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.

Duties:

• 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.

• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors

• 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

• Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan

• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation

• 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

• 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:

• 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

 

Minimum Years of Experience:

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

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