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Associate Clinical Trial Manager

ORIC Pharmaceuticals

San Diego, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Industry: Biotechnology
  • Post Date: 11/22/2022
  • Website: oricpharma.com
  • Company Address: 240 E. Grand Ave 2nd Floor, South San Francisco, CA, 94080

About ORIC Pharmaceuticals

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors.

Job Description

Member of the Study Management Team supporting the Clinical Operations Lead in the management of startup, maintenance, and close-out activities of ORIC clinical trials as well as vendor and system management as applicable.

Duties and Responsibilities:

Essential duties and responsibilities include the following.  Other duties may be assigned.

  • Assist in management of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA requirements
  • Work alongside the Clinical Operations Lead to liaise with internal and external team members (eg, CMC, Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Data Management, CRO/Vendors) to deliver high quality trial execution
  • Participate in the process of site and vendor identification, selection, and qualification
  • Assist in regulatory document collection and review
  • Assist in ongoing quality oversight of CRO-managed TMF
  • Assist in management of study vendors (eg, CRO, IRT/IXRS, laboratories)
  • Monitor the progress of trials including enrollment, monitoring report review, and clinical trial material inventory
  • Provide progress updates to Clinical Operations Lead, review and provide input to protocols, consent forms, IRB/EC materials, and other trial documents
  • Review department specific procedural plans
  • Review and identify trends in enrollment and data entry at sites and proactively interface with CRO’s clinical monitoring team
  • Verify monthly accruals from vendors and study sites
  • Assist in case report form (CRF) development and user acceptance testing of electronic data capture 
  • Assist in project review specifications for external vendors
  • Participate in data cleaning and database lock activities
  • Prepare or review patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring trip reports.
  • Develop and maintain good working relationships with internal and external team members, inclusive of Investigators and site study staff.
  • Executes meeting logistics (eg schedule meetings, distribute agendas and drafts/review minutes)
  • Provide study updates at clinical operations meetings as needed on patient recruitment, trial issues, investigator’s feedback, monitoring issues, patient enrollment issues
  • Participate in co-monitoring activities and oversight of CRO/contract CRAs
  • Participate in development of departmental processes, SOPs, and initiative
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations
Education and Experience:
  • BA/BS with science major, or an equivalent combination of education and related experience
  • At least 2 years of relevant experience in clinical operations in pharmaceutical/biotechnology company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3)
  • Must be able to thrive in an entrepreneurial, fast-paced, and dynamic work environment
  • Must be organized and be able to communicate effectively
  • Demonstrated excellence in trial management skills, with track record of successfully managing multiple tasks and priorities
  • Experience with managing study vendors (eg, CRO, IRT/IXRS, laboratories), contract and budget management not required but preferred
  • Ability to work well with global, multi-disciplinary teams
  • Experience in practical knowledge and implementation of ICH-GCP guidelines (US and ex-US regulations)
  • Experience with electronic data capture and data management software
  • Experience in the management of CRAs
  • Excellent oral and written communication skills
  • Up to 10% travel

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