the smart solution for San Francisco jobs

Clinical Trials Manager

Company: Beacon Hill Staffing Group - Pharma
Location: San Francisco
Posted on: April 17, 2018

Job Description:

The Clinical Trials Manager is accountable for the day-to-day management of operations of one to two (Clinical Trials Manager II: one to four) clinical trials, commensurate with complexity, including trial start-up, conduct, and close-out activities. This activity typically is coordinated in conjunction with one or more CROs. Position Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES: Member of the Study Team (ST) May hold the role of ST Facilitator, and is responsible for the setting of agendas, effective facilitation of ST meetings, and the timely issuance and distribution of meeting minutes Facilitates all operational activities pertaining to the execution of clinical trials 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 Assists with the resolution of questions about invoices to ensure accuracy and timeliness of vendor and site payments Reviews and tracks required documentation from clinical sites Reviews and resolves discrepancies in clinical data with CRO counterparts and clinical sites Reviews monitoring visit reports and ensures follow-up with CRO clinical trial manager(s) and/or escalation of issues as necessary Ensures that the site and subject status information in CTMS is updated and accurate; ensures timely updates to Clinical Operations line management and Senior Management Assists with ensuring regulatory compliance of clinical sites with company SOPs as well as GCP and ICH guidelines Provides input for the definition of new or revised process development, problem solving, training, etc, as needed May visit clinical sites (in conjunction with CRO, if applicable) for site evaluation, initiation, monitoring, or close-out activities. Travel within North America may be required up to 20% SUPERVISORY RESPONSIBILITIES: NONE EDUCATION/EXPERIENCE/SKILLS: Education: BS/BA degree or MS/MA degree in related discipline or equivalent combination of education and experience. May require certification in assigned area. Experience: Typically requires a minimum of six years of related experience in the clinical trials field and/or combination of experience and education/training. Experience in Biotech/Pharmaceutical industry preferred. Knowledge/Skills/Abilities: - Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States - Solid clinical research knowledge and cross-functional understanding of clinical trial methodology - Exhibits ability to learn and apply foreign regulations to the clinical trial/research process - Willingness to gain experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management - Oncology therapeutic area knowledge essential - Experience in monitoring and management of multiple sites as a Clinical Research Associate is preferred - Ability to organize and prioritize several tasks and complete them under time constraints - Applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques - Resolves a wide range of issues in creative ways JOB COMPLEXITY: Performs job duties with limited guidance from the Manager Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors Demonstrates good judgment in selecting methods and techniques for obtaining solutions Networks with senior internal and external personnel in area of expertise

Keywords: Beacon Hill Staffing Group - Pharma, San Francisco, Clinical Trials Manager, Healthcare, San Francisco, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Healthcare Jobs

School Physical Therapists Rocklin
Description: Academic/Faculty/Research opening in Rocklin, California. This and other physical therapy jobs brought to you by Maxim Healthcare Services is searching for Physical Therapists (more...)
Company: Maxim Government Services
Location: Rocklin
Posted on: 04/27/2018

Nurse Practitioner Family Or Internal Medicine
Description: Currently hiring 4 Nurse Practitioners to join an expanding private practice We are a Private Practice specializing in Family practice and Internal Medicine. Competitive pay structure of 55/an hour (more...)
Company: NSI Healthcare
Location: Elk Grove
Posted on: 04/27/2018

Traveling Post Anesthesia Care Unit RN (PACU RN)
Description: Anesthesiology opening in Sacramento, California. This and other rn jobs brought to you by We currently have a client in Sacramento,CA looking for PACU Registered Nurse Focus Staff (more...)
Company: Focus Staff
Location: Sacramento
Posted on: 04/27/2018

Travel Physical Therapy Physical Therapist
Description: Supplemental Health Care is working with a phenomenal hospital in the San Mateo, CA area.
Company: Supplemental Health Care
Location: San Mateo
Posted on: 04/27/2018

RN Registered Nurse NICU - Travel to New York
Description: RN Registered Nurse NICU --- Travel to New York br Are you looking for a rewarding travel nursing assignment as a Neonatal Intensive Care / NICU RN Registered Nurse White Glove Placement, Inc. is currently (more...)
Company: White Glove Placement Inc.
Location: San Francisco
Posted on: 04/27/2018

Therapist / Speech Language Pathologist Job in Berkeley, California
Description: Speech Language Pathologist openings for the 17/18 SY in Berkeley, CA JOIN US - AS WE WORK TO POSITIVELY IMPACT THE LIVES OF CHILDREN AND COMMUNITIES ACROSS THE US Job Details:These are school-basedServing
Company: The Stepping Stones Group
Location: Berkeley
Posted on: 04/27/2018

Optometrist - Doctor of Optometry
Description: Responsibilities Performs examinations of the internal and external structure of
Company: Vision Precision Holdings, LLC
Location: Elk Grove
Posted on: 04/27/2018

Nurse Practitioners Easy Home Assessments . Make that holiday cash ! New Grads with license welcome
Description: San Mateo, California Make that Holiday Cash Encouraged to apply are NP's with Geriatric or home health assessment experience . NEW GRADS MUST have GERIATRIC EXPERIENCE . Flexible schedules,
Company: Medsource Medical Staffing, Inc.
Location: San Francisco
Posted on: 04/27/2018

Clinical Support Specialist
Description: Overview br br Dignity Health, one of the nation's largest health care systems, is a 22-state network of more than 9,000 physicians, 63,000 employees, and 400 care centers, including hospitals, urgent (more...)
Company: Dignity Health
Location: Redwood City
Posted on: 04/27/2018

Denial Medical Coders
Description: Please only apply if you meet the qualifications and your resume must reflect your work experience. PT
Company: Mommy Jobs Online
Location: Elk Grove
Posted on: 04/27/2018

Log In or Create An Account


Forgot password?

Find us on Facebook

Find us on LinkedIn

Get the latest California jobs by following @recnetCA on Twitter!

San Francisco RSS job feeds