Kelly Scientific Resources is a specialty service of Kelly Services®. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting contract opportunity in the Emeryville, CA Area for Clinical Trial Manager
Clinical Trial/Study Manager
DESCRIPTION OF DUTIES:
The Clinical Study Manager will primarily support the Glaucoma program with efficient planning and execution of a Phase 3 Clinical study Deliverables: Initial focus will be on study start-up including identification of clinical sites, drafting of study protocol and ICF, and oversight of outsourced monitoring communication plan, as well as source document worksheets, and providing ongoing critical program support to Clinical Lead for data validation and preparedness for database lock for all.
Key milestones supported by this role will include: Selection of Study Sites by October/November 2018, finalization and approval of Protocol and ICF for the study by November 2018, readiness of study plans for approval and clinical site activations supporting First Subject in by Jan-Feb 2019, and timely completion of enrollment and Database lock in first half of 2019.
- Five or more 5+ years of clinical research experience preferably in ophthalmology with a BS degree in a scientific discipline, RN, BSN degree or equivalent; MS, PharmD and/or PhD preferred.
- Prior experience in selection and management/oversight of CROs and other Vendors required Significant experience in the oversight of day-to-day clinical operational aspects of drug development.
- Must have the ability to make high level decisions and work effectively within a team with minimal input from management, must be able to set and prioritize goals and objectives; excellent time management and organizational skills.
- Demonstrated track record of driving projects/deliverables to completion within established deadlines.
- Proven ability to manage teams.
- Strong verbal communication and scientific writing skills, and good interpersonal/group skills.
- Must be able to communicate information between team members and with senior level management both inside and outside the company.
- Must demonstrate tact and the ability to positively influence others across all organizational levels.
- Must exercise good judgment regarding routine and non-routine assignments.
- Significant knowledge of FDA and ICH regulatory requirements e.g. Guidance’s, guidelines, CFR, etc. and implementation guidelines.
- Understanding of scientific and statistical principals’ vis a vis clinical trial design and analysis/presentation/reporting of data collected in clinical trials.
- High degree of computer proficiency, preferably in MS Office environment.
- Highly detail oriented. Adaptable to changing regulatory environments.
- Flexible team player with the ability to work in a changing environment.
- Ability to work collaboratively and effectively with people from different cultures e.g., European, Asian; previous work experience with Asian company’s a plus.
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.
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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.