Study Responsible Scientist
Study Responsible Scientist
Kelly Science, Engineering, Technology & Telecom
United States
See who Kelly Science, Engineering, Technology & Telecom has hired for this role
Kelly Services is currently seeking a Senior Clinical Project Scientist (Associate Director) for a long-term engagement with one of our Global Pharmaceutical clients.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
RESPONSIBILITIES:
- Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study.
- Develops clinical research protocols, study case report forms, informed consent.
- Develops the medical review plan to support the statistical analysis plan.
- Plays a key role in the medical review of the study data and assists in coding, analysis and documentation
- Validates and interprets results of phase I - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals
- Ensures team member adherence to clinical research guidelines and safety procedures.
- Communicates detailed outcomes and results of research findings to relevant partners.
- Provides input in managing project budgets and projections.
- Serves as liaison to global clinical sites for medical questions related to the clinical research trial
- Presents study status at internal/external meetings, including investigator meetings and governance committees
- Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities
- Participates in/leads interactions with health authorities.
- Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies.
- Reviews and maintains correct standard operations, procedures and protocol
EDUCATION AND EXPERIENCE REQUIREMENTS:
- A minimum of a bachelors degree is required; and advanced degree (M.D., Ph.D. Pharm.D.) is preferred.
- A minimum of 3 years of clinical research and development, or related experience within the industry pharmaceutical, biotech, CRO, etc. is required.
- Experience in oncology therapeutic area is required, preferably Non Small Cell Lung Cancer, Prostate and or Multiple Myeloma
- Significant experience with clinical trials including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.
- Excellent written communication, oral communication, and presentation skills are required.
- The individual must have demonstrated ability to work in a team environment.
- Ability to travel up to 10% required.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research, Analyst, and Science -
Industries
Pharmaceutical Manufacturing
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See who you knowFeatured Benefits
Inferred from the description for this job
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Medical insurance -
Vision insurance -
Dental insurance -
401(k)
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