Clinical Study Lead

2 weeks ago

Basking Ridge, United States Shiftcode Analytics, Inc Full time
CLINICAL STUDY LEAD
6+ MONTHS CONTRACT
BASKING RIDGE, NJ / TARRYTOWN, NY
HYBIRD (3 DAYS/WEEK)
VISA- NO CPT/H1B

The Temp 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 is accountable for oversight of the contract and budget execution, study timelines, study budget management, and ensuring study conduct is in accordance 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, but are not limited to, 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.

This role has a 3-day minimum onsite requirement

A typical day in this role looks like:
  • 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
  • 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 development and management
  • Provides input into baseline budget development and management, facilitates internal review of the study budget for assessment of Fair Market Value
  • Ensures accurate budget management and scope changes for internal and external studies
  • 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 JOB f 2
  • Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
  • Manages and oversees study close-out activities
  • Ensures End of Study Summary is delivered and properly archived
  • 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 departmental processes and procedures
  • Works with Therapeutic Focus Area groups within Basic Research/Discovery
  • Works closely with clinical site staff, predominatly at academic institutions
  • Expected to maintain higher volume and/or greater complexity studies
  • Expected to communicate learnings, best practices and relevant information to other study leads at all levels, ensures consistency and internal alignment across staff
  • 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
  • In order to be considered qualified for this role, a minimum of a Bachelors degree with 8+ years relevant industry experience. Sponser expereince and site experience preferred.

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