Clinical Trials Manager

Job Description

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.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: Manage 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 metricsPerform CRO oversight activities such as Trip Report Review, TMF review and co-monitoring visits, per Study Plans. Provide written documentation of all activities including issues and findings in Spreadsheets or databases Co-monitor clinical study sites up to 25% of travel; write and review reports for PSSVs, SIVs, IMVs, and COVs as required Assist in the management of external vendors (e.g., clinical labs, study assessment labs) Perform operational feasibility assessments for new clinical protocols Support efforts geared to prepare clinical sites for regulatory inspections Help identify and recruit clinical investigators Review sample, investigator-prepared and IRB-approved informed consents Coordinate the design, format and content of study guides and subject instructions Coordinate the activities associated with site start-up and management Coordinate the arrangements for investigational product May coordinate the preparation, conduct and presentations at Investigator Meetings Manages the overall Investigational product accountability and reconciliation process Ensure that that CRF data queries are resolved Coordinate CRO tracking, and training, including central laboratories Provide study-specific outsourcing specifications for RFPs Coordinate CRO relationships and performance Ensure 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 With the appropriate competency and skills, may supervise staff, assign work and perform performance appraisals Experience in either starting a study up, closing out a study, or working on the maintenance phase of study

SUPERVISORY RESPONSIBILITIES: None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education: BA/BA/BSN in biological sciences or related field and seven years of related experience; or, MS/MA/MSN in biological sciences or related field and five years of related experience; or, PhD/PharmD in biological sciences or related field and zero to two years of related experience; or, Equivalent combination of education and experience.

Experience 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:

G&A and Development/Alameda: Environment: primarily working indoors, performing clerical work

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Additional Information

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.