Clinical Biospecimen Scientist Jobs in New York

Must have project management skills (develop short range plans that are realistic and effective)

Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming

PhD, MD, PharmD, or MS in life sciences with some previous experience in clinical research or clinical development experience.

Experience in working in an umbrella and/or basket clinical study design.

Proficient experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative.

Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.

Ability to manage multiple competing priorities with good planning, time management and prioritization skills

May be responsible for tracking study timelines using project management tools.

Working knowledge of clinical research regulatory requirements (e.g., GCP and ICH)

Good understanding of the principles of project planning & project management

Supporting other scientists with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.

Building analytical skills to drive operational milestones

Maintain full understanding of clinical protocol, including mentoring of more junior employees on requirements.

At least 5 years of experience in clinical development (5+ Associate Director, 8+ Director level).

Demonstrated experience creating clinical trial protocols and regulatory documentation.

Excellent communication skills (written, oral and presentation).

Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).

Senior/Clinical Scientist (based on experience)