Clinical Study Manager (CSM)

Reports To (Position): CLINICAL STUDY LEADER OR DIRECTOR CLINICAL OPERATIONS

Location: South San Francisco

Department Name: Clinical Operations 

HR Designations: Pay Status – Exempt

Objective of Position

The Clinical Study Manager (CSM) provides day to day clinical operations management of a clinical trial. Attends the study management team (SMT), may manage vendors, clinical monitors and clinical trials sites.

Essential Duties/ Responsibilities

  • May assist in reviewing clinical study protocols, informed consents, case report forms, monitoring plans, clinical study reports and other study-related documents
  • Assists in development of clinical studies and respective documents for company products
  • Assists in study / site evaluations start-up, conduct and close-out activities in addition to routine monitoring visits or co-monitoring, as required
  • May act as one of the primary contacts between the company and multiple clinical sites
  • Maintains close contact with sites by telephone, correspondence and on-site visits as required
  • Assists in preparing CROs, vendors, CRAs for a site monitoring visit to assure compliance with the study protocol, clinical trial material storage and accountability, GCP and FDA or other Health Authority regulations, and overall clinical objectives
  • Ensures preparation, management and participation in investigator meetings when required
  • Instructs investigators, study coordinators and their personnel regarding site compliance with the routine protocol, regulatory requirements and quality of data
  • Supports the training of Clinical Study Associates and / or be assigned as a buddy to colleagues
  • Interfaces, co-ordinates and addresses routine study issues with individuals in other functional areas
  • Supports the availability of clinical trial documentation and retrieves, processes and tabulates clinical or study compliance data to ensure smooth initiation, operation and timely completion of the clinical trial
  • Verifies accuracy of clinical data through comparison of the case report forms to patient records at the site and identifies and escalates discrepancies
  • Supports review of routine data, and preparation of safety, interim, and final study reports, and resolution of data discrepancies
  • Provides input into the selection of and grant contract negotiation with investigational sites and may conduct site training for the study
  • Supports the resolution of routine monitoring issues
  • Provides Clinical Operations guidance for complete and accurate databases for clinical studies
  • Supports analyses of study data and prepares clinical summaries as needed to support claims of safety and efficacy
  • Provides input in the setting and updating of study timelines for vendors
  • Provides input in CRO or vendor selection
  • Interacts with CRO personnel as needed and may oversee CRO management of 1-2 regions of a clinical trial
  • May manage one or more vendors for clinical trials in accordance with budgets and scopes of work

Requirements

  • Possesses excellent verbal, written, interpersonal skills
  • Possesses good organization and planning skills
  • Ability to manage multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
  • Ability to work both independently and in a team setting, including a matrix environment
  • Demonstrated expertise in relevant clinical operations activities
  • Experience in all phases (e.g., I, II, III) and stages (e.g., startup, maintenance, close out) of clinical operations
  • 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 knowledge of clinical trial design; understanding of the overall drug development process
  • Understanding of the regulatory environment and pathways globally, desirable
  • Demonstrated competence in adhering to and understanding standard business procedures (e.g., SOPs)
  • Proficient in using a variety of software programs (e.g., MS Office)
  • Requires the ability to sit or stand for extended periods of time

Education/ Training

  • Minimum 2 years direct study management or relevant site or clinical experience in the pharmaceutical industry
  • Bachelor degree or equivalent education / degree in life science / healthcare or nursing field preferred
  • May involve travel


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.