Clinical Trial Manager
San Diego, California
Clinical Trial Manager
Who You Are
Candidate must be:
- Self -motivated
- Sustaining to manage multiple tasks at the same time.
- Know how to work in "start-up" environment (please apply only if you have such experience)
- Nimble, dynamic, innovative – able to solve problems quickly.
- Project-oriented (this is not a CRA position, eg. not patient-facing).
Please do not apply if you need instructions for every step.
- Must have a growth mindset, be a self-starter and be “hands-on”.
- BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.
- 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 studies, both domestic and international
- 3-5 years study oversight as an in-house CTM or related experience (e.g., CRO/vendor oversight)
- Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start-up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close-out.
- Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
- Apply project management best practices to programs. Experience in novel clinical drug development.
- Experience with protocol, ICF, CRF, CSR development and review.
- Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP and country clinical research law and guidelines.
- Excellent understanding of global, country/regional clinical research guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices
- Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas.
- Strong IT skills (use of MS Office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.
What You’ll Do
- Clinical development planning and strategy,
- Clinical study planning and execution within pre-specified clinical development program timelines and budget
- Includes, but is not limited to:
- Preparation of study related materials
- Relationship management between study sites and vendors (in particular CROs)
- Supervision of study related activities
- Identification of project risks and contingency planning.
Summary of Key Responsibilities
- The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
- Provide oversight of clinical research studies across all functional areas of the drug development process.
- Prepare and assist in the development of study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, CSR development, etc.
- Assist in the development of study documents and tools including study protocols, consent forms, project plans, budgets, logs, templates, newsletters, and other documents, as needed.
- Vendor (e.g., CRO, Biometrics, IxRS, PK/Central Lab, eTMF, Safety, Independent radiology review) oversight for adherence to budget, timelines, and organizational objectives of individual protocols/programs
- Manages the oversight of sample collection (i.e., biopsy/tissue samples, lab samples, scans, PK samples)
- Obtains and maintains in-depth understanding of the study protocol and related procedures to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Coordinates and manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
- Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
- Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
- Works with vendors to prepare and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
- Supports financial management of the study which includes review and approval of site and vendor invoices.
- Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate.
Why Work Here
- Our company is looking for a detail-oriented Clinical Trial Manager that is very good at problem solving to help the company move its development needle to drug approval.
- Benefits Offered Home based, Medical.
- Employment Type: Full – There is a probation period of 2 months to determine fit.
- We are a very entrepreneurial company with a lean team of do-ers.
- Our company has a very small team so Candidate must be able to do and solve problem without reliance on others.
Travel may be required up to 25% of your time.
Job Type: Full-time
Pay: $80,000.00 – $140,000.00 per year
We are an entrepreneurial company that a mindset of getting things done. That has always meant we worked virtually and remotely, without fixed schedules – so long as the work gets completed. COVID-19 has not slowed down the pace of the company.