Clinical Study Manager
Clinical Study Manager
Job Number: 19-09924
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Study Manager for our client in South San Francisco, CA.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Responsible for working collaboratively with the members of the development team (including a medically qualified individual) to establish the clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-II clinical trials, and for designing/executing and reporting protocols for studies included in the development plan.
- Depending on experience, may contribute to or be primarily responsible for formulation of clinical development plans.
- Contributes to or may independently design protocols, amendments and conduct data review, analysis and interpretation.
- Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead or medically qualified individual.
- The specific components of safety data review are detailed in the Safety Data Review Guide - for Clinicians and SAF09 SOP (pharmacovigilance).
- May contribute to or be primarily responsible for Go-No recommendations for the compound, including recommendation to advance to FIH after review of the preclinical package and involvement with transition and preparation to Phase III.
- In conjunction with members of the development team may prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
- Interface with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators.In conjunction with study team is responsible for the on-time and within-budget execution of protocols.
- May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues.
- May act as clinical representative in in-licensing activities such as due diligence reviews and reports.
- May transition early development clinical programs into late stage development.Demonstrated experience with GCP and the ability to apply
- policies and SOPs
- Organizational Relationships:
- This position reports into a Global Clinical Lead (MD Clinician).
- This position works in a matrix organizational structure with a variety of functional clinical development disciplines (Clinical Pharmacology, Translational Oncology, Clinical Operations, Statistics, Regulatory, Legal, Data Management, Programming, etc. ) to develop and execute a clinical study and also to close out and report on the trial.
- Must have proven scientific writing skills and good communication skills.
- Demonstrated experience in writing clinical trials, developing clinical programs, executing clinical programs and reporting out clinical programs in the oncology therapeutic area (solid tumors/hematology)
- Demonstrated experience in early oncology clinical development.
- Ability to work in a matrix organizational structure.
- Ability to work in a fast-paced environment.
- Drug Development Skills - demonstrated experience in a clinical development environment, understanding and adherence to GCPs, SOP, and other international guidances.
- Business Acumen - - knows how businesses work; knowledgeable in current and possible policies, practices, trends and develoments affecting our business and organization.
- Empowered to make observations and recommendations to establish a more efficient working environment.
- Demonstrated Experience
- 10 yrs as an Oncology Clinical Scientist / Study Clinician developing and executing clinical studies
- Requires individual to be medically qualified.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jay Lucas | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Job Status: Contract/Temporary