Clinical Trials Manager

Durect Corporation - Cupertino, CA4.5

Full-timeEstimated: $99,000 - $140,000 a year
EducationSkills

NO RELOCATION OFFERED - LOCAL CANDIDATES ONLY

MAIN PURPOSE OF POSITION:

The Clinical Trial Manager (CTM) will perform and coordinate key aspects during the conduct and monitoring of clinical trials in accordance with GCP/ICH Guidelines and DURECT SOPs. This includes project planning, budget, and contract Clinical Research Organizations (CRO) management. This position will work closely with the other members of the Clinical Development Team (including Medical Monitor, Project Management , Clinical Pharmacology, Regulatory, Legal, Finance and QA) and will also interact with CROs, Investigator sites, central laboratory vendors and other external vendors.

MAIN DUTIES AND RESPONSIBILITIES:

  • Participate in all aspects of clinical trials including study start-up activities through close-out.
  • Develop and track overall study budget.
  • Provide project planning updates to ensure adherence to timelines
  • Communicate regularly with clinical investigative site personnel, (including study nurses, coordinators, and physicians), contract research organizations (CROs) and internal DURECT key personnel to ensure clinical project goals are achieved within the team goals and according to SOPs.
  • Visit clinical sites and CROs whenever needed.
  • Review and approve CRA staff assignments proposed by CROs.
  • Ensure compliance with protocol and project guidelines as well as GCP/ICH Guidelines, consistency w/ Sponsor and CRO SOPs.
  • Responsible for participating in program specific weekly teleconferences with CROs. Escalate project issues to the attention of the Clinical Operations Director as well as the Medical Monitor/Project Physician in a timely fashion.
  • Track the day-to-day progress of clinical site activities and updates the appropriate.
  • Participate in editing and review of clinical study protocols and investigator brochures as needed.
  • Review regulatory documents and/or regulatory checklists to ensure completeness prior to study site initiation and study drug delivery.
  • Regular review of monitoring reports, EDC screens, data queries, data query resolutions to ensure protocol compliance. Perform ongoing data review to ensure safety and high quality data collection, for accuracy and completeness.
  • Review qualifications of investigators and site staff and make recommendations for their participation in a clinical study.
  • Review of Trial Master Files prior to archiving.
  • Coordinate the shipment of study supplies to trial sites as needed.
  • Work with Clinical Ops team to manage vendor and site budgets

ADDITIONAL DUTIES AND RESPONSIBILITIES:

  • Support various needs required by regulatory applications and submissions.
  • Update SOPs for Clinical Operations when required
  • Participate in editing and review of documents such as clinical study protocols, clinical study reports, investigator brochures and documents required in regulatory submissions as needed.
  • Contribute to verifying accurate navigation of hyperlinks within the eCTD format to insure submission readiness.
  • Other tasks or projects as assigned based upon company needs.

JOB SPECIFICATIONS:

REQUIREMENTS

Knowledge/Education:

  • Undergraduate degree or RN/BS Degree in Biological Sciences, Biomedical Sciences or related field.
  • Must have knowledge of Good Clinical Practices (GCP) and FDA Guidelines and Regulations

Job Experience:

  • 7+ years of Clinical Research experience for Senior level role
  • Prior experience managing CROs and vendors.
  • Proficient report writing (e.g., meeting minutes, monitoring reports, evaluation reports, letters to sites or vendors) and verbal reporting

Skills/Competencies:

  • Strong computer skills (Word, Excel, PowerPoint)
  • Must be able to work independently and as part of a team with high degree of professionalism
  • Ability to effectively and professionally communicate (written and verbal) at all levels
  • Must have keen sense of urgency and time management skills to convey critical issues to supervisor and/or Clinical Development Team

Working Conditions:

  • Some work is performed in a typical office work environment and some work in a clinical environment
  • Occasional travel required

Job Types: Full-time, Contract

Experience:

  • Clinical Research: 7 years (Required)

Education:

  • Bachelor's (Required)

Work authorization:

  • United States (Required)

Contract Length:

  • Varies