Senior Clinical Trial Manager Job
|Location: San Francisco, California
||Date Posted: 5/29/2019
|Job Code: EX-CTM1
Plans and manages clinical trials. Oversees internal and external staff for the timely and quality implementation of trials. Oversees CRO activities. Coordinates the training of clinical and other staff. Performs performance appraisals on direct reports.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Independently 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 the company in 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
Perform 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
- Coordinate CRO tracking, and training, including central laboratories
- Provide study-specific outsourcing specifications for RFPs
- Coordinate CRO relationships and performance
- Ensure compliance with company 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
- BA/BA in biological sciences or related field, or BSN, MS, MSN, PharmD or MPH
- Typically requires a minimum of 9 years of related experience in life sciences, including 7 years in experience in clinical research and at least 4 years of study management
- Proven ability to provide clinical expertise to a clinical development program
- Proficiency in clinical studies involving complex design
- Experience in independent preparation of clinical sections of IND, BLA, or NDA
- Experience with management of multinational clinical trials
- Demonstrated matrix leadership skills.
- Detailed knowledge of regulations and guidelines
- Ability to anticipate and resolve problems
- Ability to write and present clearly especially on scientific and clinical issues
- Ability to work effectively in a team/matrix environment
- Excellent interpersonal, organizational, supervisory and project planning skills.
- Proficiency in the preparation and review of clinical sections of study reports and BLA/NDA.
- Demonstrated professional collaboration skills
- Experience in all phases of drug development, including international trials
- Impacts the results of a department or a project influencing both the tactical work and the direction of future endeavors for the group.
- Responsible for ensuring achievement of own or others' revenue targets.
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.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 29 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required:
|Contact Name: GPAC