Clinical Study Leader (CSL)

Reports To (Position): Director Clinical Operations 

Location: South San Francisco

Department Name: Clinical Operations 

HR Designations: Pay Status – Exempt

Objective of Position

The Clinical Study Leader (CSL) leads activities associated with the execution, evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH / GCP guidelines. Leads study management team (SMT), including oversight of CRO and vendors where applicable. Can line manage clinical operations staff.

Essential Duties/ Responsibilities

  • Responsible for the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial plans, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
  • Contributes to development of study budget and ensures effectiveness of site budget / contract process and ensures effectiveness of site budget/contract process
  • Monitors and tracks clinical trial progress and provides status update reports
  • Responsible for the selection of investigators and study sites, unless designated to CRO
  • Manages project timelines and vendor performance to meet study team, departmental and corporate goals
  • Identifies and escalates site, vendor and study-related issues recommending corrective actions, as appropriate
  • Provides input to development of RFPs and participates in the selection of sites, CROs and vendors
  • Contributes to preparation and maintenance of study timelines, deliverables and overall study management
  • Coordinates all aspects of a clinical study including the design, format and content of CRFs, study guides, study reference binders, patient diaries and forms including participating in the EDC and IVRS specification process and UAT
  • Oversees and trains CROs, vendors, investigators, field monitors and study coordinators on study requirements, when required
  • Responsible for selection of CRO study staff and coordinating training including documentation
  • Coordinates and manages investigator selection, investigator meetings and presentations, training of study Field Monitors, Investigational Product including overall accountability, study related issues recommending corrective actions and / or escalating to Director
  • Provides oversight to clinical trial sites for adherence to protocol and GCP and to track and resolve issues as required
  • Manages and participates in the review of clinical data at the CRF, data listing and report table levels
  • Oversees timelines for the development of abstracts, presentations and manuscripts, as needed
  • May manage and coordinate clinical trial vendors (e.g., IVRS, central labs, IRB and central ECG)
  • Participates in activities to support project priorities within functional area
  • Serves as a resource for others within the company for clinical trials management expertise
  • Leads with minimal supervision in the planning of investigator meetings and making presentations, as required
  • Can represent Clinical Operations at the Project Team level for individual studies, as appropriate
  • Partners with other research and development groups to achieve deliverables
  • Can manage Clinical Operations staff and conduct performance appraisals
  • Supports the training of Clinical Operations staff and / or be assigned as a buddy to colleagues
  • Participates in department settings / initiatives, including attending additional meetings as required and interacts in a positive and professional manner

Requirements

  • Possesses excellent verbal, written, interpersonal skills
  • Possesses decision-making and organizational skills
  • Demonstrated expertise in relevant clinical operations activities
  • Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results
  • Ability to problem solve and delegate tasks as appropriate
  • Ability to prioritize multiple tasks and to participate in multiple departmental or interdepartmental strategic initiatives with limited supervision
  • Demonstrates thorough knowledge and understanding of required regulations including FDA and /or EMEA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials
  • Demonstrates strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Ability to collaborate effectively with the study team, cross-functional team members, and external partners
  • Ability to support SOP development and implementation
  • Ability to generally understand, interpret, and explain protocol requirements to others

Education/ Training

  • BA / BS / MS in a scientific discipline
  • 6+ years of relevant clinical experience in a CRO or pharmaceutical firm
  • CRA / CSM experience preferred and at least 3 years of study management experience
  • Experience in oncology preferred
  • Experience in global trials preferred


Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. 

Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.