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30 days old

Assistant Director, Clinical Trial Management

Kelly Services
San Diego, CA 92108
**Direct** **Hire, 100% Remote, Less than 10% travel**


**Associate Director, Clinical Trial Management (Oncology)**


Kelly Science & Clinical is seeking a talented and motivated clinical operations professional to support our clients oncology clinical trials.


**The Associate Director, Clinical Trial Management** will be responsible for leading and managing clinical trial operational activities for Ph I-II trials. This individual will ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs, and business guidelines. The successful candidate must have a good knowledge of clinical operations, GCP and FDA regulatory environment, and oncology trial experience is required. This is a full-time position.


**Responsibilities:**

Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.

Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs and attend co-monitoring visits.

Work with CROs and investigative sites to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives.

Work with CROs to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.

Establishes and maintains study timelines and tracks clinical trial progress.

Provide strategic clinical trial input related to study logistics, management and oversight of enrollment (including forecasting), clinical supply and drug supply, data review and data cleaning and Trial Master Files.

Review and contribute to study Protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, and other study-related documents.

Perform financial management, including review and approval of site and vendor invoices, investigator contracts and site payments. and track and coordinate trial related materials, including clinical trial supplies and laboratory samples.

Serve as a liaison and resource for investigational sites.

Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.

Performs cross-functional User Acceptance Testing (UAT) of the integrated clinical databases

Coordinate/plan investigator meetings and/or site.

Organize and manage internal team meetings and other trial-specific meetings.

Assist with clinical operations process development.

Attend and participate in virtual meetings with Shanghai-based Clinical Operations team

Some travel will be required (no more than 10%)


**Qualifications:**


+ Bachelors or Masters degree or equivalent in a scientific or health care field

+ CRA working experience, in Oncology Trials

+ Experience managing oncology clinical trials, preferably in early development phase I

+ Minimum of 5 years of experience in the following:


+ Direct clinical trial management experience, preferably in both a CRO and pharmaceutical setting

+ CRO/vendor management

+ Monitoring of budget scope

+ Clinical site monitoring of oncology trials

+ Data management/biostatistics processes and pharmacovigilance


+ Good working knowledge of ICH/GCP

+ Experience performing User Acceptance Testing (UAT)

+ Experience with various clinical trial systems (EDC, CTMS, TMFs), trial master file organization, regulatory documents, inspection preparation/readiness (site and sponsor) required (Medidata Rave experience preferred)

+ Clinical operations experience at a small or mid-size company

+ Experience in running an oncology trial from start to finish

+ Leadership competencies, building strong relationships with peers and cross- functionally with partners outside of team to enable higher performance

+ Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials

+ Self-motivated individual comfortable with shifting priorities and regular change

+ Strong team orientation, with excellent written and oral communication skills and interpersonal skills.

+ Mandarin language skills helpful but not required

+ Pacific Time Zone, or ability to participate in regular evening calls due to counterparts Shanghai location


\#P1




**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-08-29 Expires: 2022-10-29

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Assistant Director, Clinical Trial Management

Kelly Services
San Diego, CA 92108

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