Job title: Senior Clinical Scientist
Company: Actalent
Job description: Job Title: Senior Clinical ScientistJob DescriptionIn collaboration with the clinical teams for a specific product candidate, the Clinical Scientist is responsible for designing, preparing, and initiating study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice. The role involves conducting literature research for the assigned clinical product candidate, working with medical monitors to enable interaction with clinical sites and thought leaders in oncology, and assisting sites in the efficient completion of clinical trials. The role requires delivering high-quality scientific presentations on our investigational agents to physicians and other key external customers, while maintaining clinical and technical expertise in the therapeutic area of Oncology.
- In collaboration with the clinical study teams for a specific product candidate in clinical development, designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
- Interacts with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols.
- Researches and assists in the selection of investigators for clinical studies.
- Conducts appropriate literature research for the assigned clinical product candidate.
- Collaborates with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
- May act as contact of the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.
- Collaborates with clinical operations and other team members in the development of agendas, training materials, and presentation for site visits, investigator meetings, and other study related venues
- Participates in internal safety meetings, analyzes, and reports potential safety events.
- Collaborates with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.
- Contributes to the writing and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.
- Provides feedback on emerging clinical and competitive trends.
- Coordinates and facilitates clinical oncology studies by developing and maintaining excellent working relationships with study investigators.
- Delivers high quality scientific presentations on investigational agents to physicians and other key external customers.
- Maintains clinical and technical expertise in the therapeutic area of Oncology.
Hard Skills
- MUST have 3+ years as a clinical scientist within oncology
- MUST have 5+ years experience as a clinical scientist at the sponsor level
- Pharm.D, PhD or MD preferred
- Detailed knowledge of clinical trial implementation and drug development process
- General knowledge of other related disciplines in the execution of clinical trials
- Comprehensive and detailed knowledge of clinical trial implementation and drug development process.
- Experience in the design, execution, and reporting of clinical trials in oncology with small and large molecule drug candidates.
- Identifies and implements methods and procedures to achieve results with high quality.
- Performs a variety of complicated tasks with a wide degree of creativity and latitude.
- Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
- May lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
- Applies strong analytical and business communication skills.
- Highly organized and able to work under tight timelines
- Good public speaking and presentation skills
Soft Skills
- Highly organized and able to work under tight timelines
- Good public speaking and presentation skills
- Strong analytical and business communication skills
Work SiteThis is a hybrid position requiring 2-3 days on-site in Alameda, California.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
Expected salary:
Location: Alameda, CA
Job date: Fri, 21 Jun 2024 00:11:15 GMT
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