Associate Director, Clinical Operations

Location
Menlo Park, CA
Posted
Oct 09, 2021
Ref
1123
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Job Description:

The Associate Director, Clinical Operations provides expertise and oversight over multiple clinical trials or a clinical program to ensure the trials are conducted in accordance with the protocols, SOPs, GCP and departmental and corporate goals. Provides leadership and direction to the Clinical Operations teams in the management of CROs and other vendors. Provides Clinical Operations expertise in cross-functional meetings and corporate SOPs and initiatives.

Responsibilities:
  • Ensure that Good Clinical Research Practice (GCPs) and Corcept clinical SOPs are met throughout the clinical trials/programs overseen by the Clinical Operations department.
  • Manages cross-functional components of the clinical programs contributing expertise in all operation activities pertaining to the execution of clinical trials; ensures teams have all necessary resources available to execute on plans. Supervise all study programs.
  • Contributing member of various study and program teams such as the Study Team Meetings; provides direction to the CTMs in creating meaningful agendas, documenting and tracking outcomes and deliverables.
  • Participates in the preparation of study budgets; negotiation of contracts and vendors; supports invoice review through payment.
  • Generate answers to regulatory queries when assigned by the program management or clinical teams.
  • Contributes in the development of study protocol to ensure that all requirements are met.
  • Reviews informed consent forms ensuring that they are in agreement with the protocols and required elements.
  • Oversees vendors in conjunction with study managers to ensure ensuring compliance with all protocol and regulatory requirements using appropriate Quality Assurance procedures.
  • Provide the clinical teams and program teams with information regarding CROs and clinical site performance and recommend remediation when needed.
  • Contributes in the identification and development of departmental policies and oversees and their implementation.
  • Contributes to definition, development and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices
  • Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed.
  • Practices professionalism and integrity in all actions and in relationships with Corcept management, supervisors, team members, direct reports and vendors. Exhibits and models leadership behavior through communication and appropriate temperament. Ability to have difficult/crucial conversations with tact.  Demonstrated ability to foster and imbue concepts of teamwork, cooperation, self- mastery, and flexibility to get the work done.  Maintains composure under difficult circumstances.
  • Other duties as assigned
Preferred Education and Experience:
  • Minimum B.S. / B.A. (science or health care field) or RN.
  • Minimum 12 years clinical operations experience.
  • Experience in project management useful.
  • Management experience in including outsourcing to Contract Research Organization (CRO
  • Previous association with a clinical program for which a regulatory market application was filed is desirable.
Preferred Skills, Qualifications, or Technical Proficiencies:
  • Leadership: ability to guide study teams and to coordinate across multiple disciplines to achieve study goals and timelines
  • Management: ability to lead staff toward common goals by providing guidance to subordinates and teams based on organization goals and company policy
  • Detailed knowledge of the clinical trials process and of the application of SOPs.
  • Detailed knowledge of GCP/ICH regulatory requirements.
  • Knowledge of drug product supply requirements.
  • Demonstrated leadership skills, especially leadership by influence.
  • Guides the successful completion of major programs, projects and/or functions.  Has extensive experience leading multiple projects involving complex issues and decision-making
  • Excellent oral and written communication skills.
  • Ability to handle multiple tasks with competing priorities.
  • Self-direction in work habits.
  • Ability to deal regularly with conflict in a direct and productive manner.
  • Ability to utilize a wide range of computer applications and tools.