Associate Director : Clinical Operations
|Job Title:||Associate Director : Clinical Operations|
|Location:||San Francisco, California|
|Contact Name:||Isabella Wang|
|Job Published:||September 18, 2019 22:31|
This collaborative position will manage clinical operations and execution of global clinical studies for the Company's various products. This position functions as a key contributor to directly oversee vendors, including clinical sites, clinical development partners, and additional internal departments, to carryout successful clinical trials.
Primary Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:
- Develop protocols which can be implemented by team to ensure adherence to all documentation requirements and process.
- Set and manage well-defined clinical project timelines and milestones with a variety of clinical development and executive teams in order to solve issues that may jeopardize timelines and deliverables.
- Act as lead and liaison for vendors in assigned clinical studies/programs, providing Company representation and adherence to project scope, deliverables and timetables.
- Coordinate and manage activities with the Company's development partners, CRO and global clinical sites from study initiation to close out Implement protocols with the CRO and ensure adherence to all documentation requirements and process.
- Act as a as primary liaison and key collaborator with clinical teams of development partners on assigned studies/programs.
- Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved.
- Collaborate with additional functional areas and consultants, such as Process Sciences, Project Management, CMC, Quality Systems, and Regulatory Affairs in order to successfully coordinate assigned clinical studies/programs
- Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory (PK/PD) data, data cleaning status for assigned trials/programs, etc.
- Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, investigator brochure, clinical study reports, INDs/CTA's, NDA's/MAA's, annual regulatory reports, etc.
- Oversee the development, forecasting, monitoring, and reporting of assigned clinical trial budgets
- Develop and contribute to finalization of clinical project timelines to meet critical company milestones; recognize and escalate issues that may jeopardize timelines and deliverables, or lead to out of scope expenses
- May coordinate RFP process, review vendor proposals, and negotiate clinical budgets for assigned trials/programs
- Conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff, and/or with Compliance personnel, including pre-study qualification visits, vendor qualification visits, routine study visits, trial master file review visits, etc.
- Monitor the maintenance of the clinical trial master files per Company SOPs. Review clinical study files for completeness periodically throughout and at the completion of clinical trials and prior to archiving.
- Organize and run assigned clinical study team meetings and teleconferences.
- Facilitate study start up with CROs and clinical sites as necessary, including, work with CRO to complete template clinical documents, such as, ICF, source document worksheets, CRF specifications, and CRF documents, clinical site agreement, and other study documentation.
- Develop or contribute to the writing and implementation of Standard Operating Procedures (SOPs) and standard forms to support clinical operations, and study-specific guidelines
- Oversee, as well as collaborate with other Company staff to ensure clinical trials are completed in compliance with FDA regulations, ICH guidelines for Good Clinical Practices (GCP) and the conduct of clinical trials.
Experience, Education, Training, Traits:
- BA/BS and direct relevant experience in global drug development required, advanced degree (MS/PhD) in a life science major is preferred.
- 7+ years of experience of biotech/pharmaceutical clinical operations experience, specific to a mix of sponsor trial management experience and clinical CRO experience, i.e., managing CRO activities, contracts and ongoing relationships.
- Must have experience in managing the execution of complex phase 1-3 global clinical trials, preferably in inflammation or oncology-related clinical therapeutic areas; P1 experience is a plus.
- Strong experience in CRO and vendor management to support global clinical trials
- Strong knowledge of FDA/EMEA regulations and ICH/GCP guidelines regarding clinical trial management.
- Demonstrated skills in writing/reviewing clinical study protocols, CRF, and study documentation development, CSR's, regulatory documents (including IND/CTA, NDA/MAA documents and annual/periodic updates).
- Understanding of data management, statistics and medical writing processes for clinical development.
- Team-oriented with excellent communication and interpersonal skills demonstrated ability in managing indirectly
- Ability to "roll up your sleeves" and individually contribute results to clinical operations and company-wide goals
- Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects.
- Ability to travel domestically and internationally. Some travel will take place on/over weekends.
- Perform other related tasks as requested.
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