Temp- Senior Mgr Clinical Study Lead

Location
Working from home
Posted
Jul 17, 2021
Ref
24969BR
Required Education
Bachelors Degree
Position Type
Full time
The Senior Clinical Study Lead (CSL) - Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical studies/research collaborations from study design, through execution, to study close out. Additionally, there are responsibilities for initiation, oversight and completion of CES Ops continuous improvement and Strategic Imperatives workstreams. The Sr. CSL will be accountable for the oversight of the contract and budget execution, study timelines, study budget management, and compliance with, Regeneron Standard Operating Procedures (SOPs), CES Ops Business Practice Tool processes and ICH/GCP, as applicable. The CES Ops portfolio is dynamic in nature; study types include less complex data transfer agreements, retrospective sample/data acquisition studies to more complex prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies. This role will interface heavily with Basic Research/Discovery as well as with clinical site staff, predominately at academic institutions. In rare instances the more complex studies may require out-sourcing to Clinical Research Organizations (CROs); the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role may be responsible for direct line management.

A typical Day might include the following:

  • Leads the cross-functional study team responsible for clinical study/research collaboration delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study from start up to close out
  • Provides operational input into research plan and/or study protocol development
  • Ensures development of study specific documentation such as samples management plans and data management plans are completed on time and in accordance with the study protocol.
  • Oversees set-up and maintenance of study systems which may include Clinical Trial Management System (CTMS), Trial Master File (TMF), study SharePoint etc.
  • Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors, if appropriate
  • Provides input into baseline timeline and budget development and management
  • Oversees and ensures the CROs and Third-Party Vendors are in alignment and are delivering per the scope of work
  • 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 departmental processes and procedures
  • Works closely with Basic Research/Discovery, Early Development Medical Directors and clinical site staff, predominately at academic institutions
  • May be 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


To be considered for this opportunity:

  • Bachelor's degree and minimum of 8 years relevant industry experience. Advanced degrees may be considered in lieu of relevant experience.
  • Demonstrated interpersonal, critical thinking & leadership skills
  • Strategic and innovative mindset, challenges status quo when appropriate
  • Ability to build productive teams and collaborations
  • Proven ability to work across different levels of complexity, different therapeutic areas and continuous improvement work
  • Flexible, able to operate effectively in ambiguous situations
  • Ability to understand and implement the strategic direction and guidance
  • 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
  • Demonstrated vendor management experience
  • Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, EDC
  • Experience in clinical study operations including experience developing protocols and key study documents
  • Knowledge of ICH/GCP
  • Effective project management skills, cross-functional team leadership and organizational skills
  • Scientific background, experience in translational research and/or basic research preferred


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.