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Clinical Trials Manager at Exelixis, Inc.

Posted in General Business 30+ days ago.

Type: Full-Time
Location: Alameda, California





Job Description:

SUMMARY/JOB PURPOSE:

Coordinates the activities associated with the evaluation, initiation and management of clinical trials. Manages clinical studies, including CRO oversight. Coordinates the training of staff involved in trial management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:


  • Manages clinical trials, including those conducted through Contract Research Organizations

  • May hold the role of Study Team (ST) Facilitator, and is responsible for the setting of agendas, effective facilitation of ST meetings, and the timely issuance and distribution of meeting minutes

  • Serves as primary contact for Exelixis functional area representatives and vendors and is responsible for protocol execution

  • Maintains regular internal contact with relevant departments such as Regulatory Affairs, Drug Safety, and others as necessary

  • Responsible for the day-to-day interaction with CROs in the execution of ongoing clinical trials

  • May assist with the development and review of study protocols, informed consent forms, case report forms, monitoring plans, study materials and monitoring tools

  • Establishes study milestones and ensures accurate tracking and reporting of study metrics

  • Performs CRO oversight activities such as Trip Report Review, TMF review and co-monitoring visits, per Study Plans. Provides written documentation of all activities including issues and findings in Spreadsheets or databases

  • Co-monitors clinical study sites; writes and reviews reports for PSSVs, SIVs, IMVs, and COVs as required

  • Assists in the management of external vendors (e.g., clinical labs, study assessment labs)

  • Performs operational feasibility assessments for new clinical protocols

  • Supports efforts geared to prepare clinical sites for regulatory inspections

  • Helps identify and recruits clinical investigators

  • Reviews sample, investigator-prepared and IRB-approved informed consents

  • Coordinates the design, format and content of study guides and subject instructions

  • Coordinates the activities associated with site start-up and management

  • Coordinates the arrangements for investigational product

  • May coordinate the preparation, conduct and presentations at Investigator Meetings

  • Manages the overall Investigational product accountability and reconciliation process

  • Ensures that that CRF data queries are resolved

  • Coordinates CRO tracking, and training, including central laboratories

  • Provides study-specific outsourcing specifications for RFPs

  • Coordinates CRO relationships and performance

  • Ensures compliance with Exelixis policies and procedures.

  • May assist in the preparation of Clinical Study Reports, Annual IND safety reports and clinical summaries, as required.

  • May monitor clinical sites for adherence to protocol and GCP

  • May supervise staff and assign work

SUPERVISORY RESPONSIBILITIES:

  • None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:


  • BA/BA/BSN in biological sciences or related field and a minimum of seven years of related experience; or

  • MS/MA/MSN in biological sciences or related field and a minimum of five years of related experience; or

  • PhD/PharmD in biological sciences or related field and zero or more years of related experience; or

  • Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

  • Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research

Knowledge/Skills:


  • Experience in either starting a study up, closing out a study, or working on the maintenance phase of study

  • Experience with development of prospective site-selection criteria

  • Protocol development experience

  • Familiar with advanced concepts of clinical research

  • Ability to deal with time demands, incomplete information or unexpected events

  • Experience in interactions with outside vendors, e.g., CROs and contract labs

  • Experience with administration of site budgets and grants with supervision

  • Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations

  • Demonstrated ability to write and present clearly using on scientific and clinical issues terminology

  • Advanced computer skills

  • Good organizational and planning skills

  • Strong interpersonal skills and communication skills (both written and oral)

  • Ability to work effectively in a team/matrix environment

  • Ability to understand technical, scientific, and medical information

  • Familiar with basic concepts of clinical research

  • Ability to problem-solve

WORKING CONDITIONS:


  • Environment: primarily working indoors, performing clerical work

  • Up to 25% of travel

#LI-KN1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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