Job Description
The Clinical or Senior Clinical Trial Manager is a key member of the clinical operations team that is implementing a number of early-stage clinical programs evaluating multiple investigational therapeutic drugs for chronic diseases. This is a temp-hire, hybrid role, requiring 3 days a week onsite in South San Francisco at a great biotech start-up with seasoned leaders and a terrific culture.
Responsibilities: - Develop and execute high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies.
- Assist with the selection of Service Providers and investigational clinical sites.
- Manage Service Providers including training and oversight
- Draft and coordinate study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports.
- Develop and maintain study timelines and study budgets
- Prepare interim/final clinical study reports.
- Contribute to the development of abstracts, presentations, and manuscripts.
- Monitor and track clinical trial progress and upkeep of status update reports.
- Identify program risks and development and implementation of mitigation strategies.
- Set up of (e)TMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
- Ensure GCP compliance and inspection readiness are maintained throughout study conduct.
- Perform oversight of central laboratories and other ancillary vendors during start-up, conduct, and close-out.
Requirements: - Bachelor’s degree and/or RN degree is required.
- A minimum of 5 or more years of clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required.
- In depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guidelines, and other applicable regulations and practices is required.
- US based clinical trials is required
- Experience of early clinical development, particularly with MASH, antiviral, or anti-infectious disease compounds is strongly preferred.
- Must have excellent teamwork, communication, decision-making and organizational skills plus a thorough knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Excellent communication, organizational, negotiation and interpersonal skills required.
- Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues
Estimated Min Rate : $56.00
Estimated Max Rate : $80.00
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Job Tags
Contract work, Temporary work, Interim role, 3 days per week,