Kelly Services Clinical Trial Manager Associate in Foster City, California
Kelly Scientific Resources is the world's most recognized brand in Scientific Staffing with more than 100 locations in the North America, Europe and the Pacific Rim. Our scientists contribute to the research and development of products that are used daily in the home, such as medical devices or pharmaceutical products. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. We currently have an exciting opportunity in the San Francisco area as a Sr. CTMA -Late Phase.
Purpose: plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects:
Serves as the key operational contact with external investigators and internal stakeholders.
Has ability to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety implications.
Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or product support are processed in a timely manner and to high quality.
Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study remains on track.
Maintains efficient collaboration with company’s Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner.
Acts as primary contact for study drug planning and shipping with Materials & Logistics.
Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
Provides monthly study updates to the appropriate internal stakeholders.
Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable.
Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies.
Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations.
Organizes and leads review/approval meetings for CO proposal.
Actively participates in Clinical Operations Quality Initiatives.
Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
Performs administrative duties in a timely manner as assigned.
May contribute to sponsored studies:
With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
Assures site compliance with the routine protocol and regulatory requirements and quality of data.
May resolve routine monitoring issues.
Assists in the setting and updating of study timelines.
Assists in CRO or vendor selection.
With guidance from supervisor coordinates CROs or vendors.
May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
May participate in abstract presentations, oral presentations and manuscript development.
Interfaces with individuals in other functional areas to address routine study issues.
May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
Travel is required.
Skills/Experience requirements :
Skills required demonstrating key core values of Integrity, Teamwork, Excellence, and Accountability
Strong analytical, conceptual and business judgment skills.
Excellent planning, organizational and administrative skills.
Demonstrate core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results while working independently
Significant technical expertise and learning ability with demonstrated flexibility required to maintain pace with best practices in the industry
Effective communication skills, both oral and written.
Excellent problem solving ability.
Effective project and time management skills.
Tenacity and perseverance to ensure high level customer service.
Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration.
High sense of urgency and commitment to excellence in the successful achievement of objectives and program execution.
Good understanding of financial systems and contracting process (desirable, but not required).
Ability to understand clinical study protocols and efficient project management skills
Working knowledge of ICH/GCP required. Phase research experience preferred.
Working knowledge of MS Word, PowerPoint, Outlook, and Excel.
Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials and ability to understand clinical study protocols
Bachelor's degree in Science with relevant project management experience, or equivalent/advanced Degree in science with relevant project management experience
Minimum 3-5 years pharmaceutical industry experience with knowledge of drug development process.
Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
Ability to develop tools and processes that increase measured efficiencies of the project.
Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
Must have a general understanding of functional issues and routine project goals from an organizational perspective.
6 month contract to start
Please apply now for immediate consideration!
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.