Clinical Development Scientist

Planet Pharma

0-2 years

Not Disclosed

Redwood City

10 Jan. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Development Scientist
Location: Redwood City, CA 94063
Employment Type: Contract
Job Category: Clinical Development and Operations
Job Number: 616589
Is Job Remote?: No
Country: United States

Job Overview

Planet Pharma is seeking a Temp Clinical Development Scientist to contribute to the scientific, clinical, and operational aspects of clinical study protocols. This role will involve working with cross-functional teams to execute and monitor 1-3 clinical studies. The candidate will focus on data review, interpretation, and communication with both internal and external stakeholders to support clinical trial objectives, with a strong emphasis on oncology and early-stage development.

Key Responsibilities

Data validation: Ensure data accuracy by checking against predefined criteria and validation rules, identifying discrepancies and missing values.
Data reconciliation: Compare data from various sources to ensure consistency and accuracy.
Query management: Generate and resolve queries to clarify or correct discrepancies.
Data standardization: Ensure data are formatted according to protocol specifications and regulatory standards (e.g., CDISC, SDTM).
Audit trails and documentation: Maintain detailed records of data changes and justifications, ensuring traceability and GCP compliance.
Contribute to the development of clinical documents (protocols, study reports, abstracts, manuscripts, etc.).
Conduct quality control checks of clinical data summaries for internal and external stakeholders.
Ensure trial implementation in line with the protocol and assess issues related to protocol conduct or subject safety.
Communicate with internal and external stakeholders (investigators, study sites, vendors) to support clinical trial objectives.
Conduct literature reviews as needed.

Required Qualifications

Bachelor’s degree in a relevant field.
Minimum 4 years of experience in clinical development, including expertise in medical data review and study reporting.
Strong ability to prioritize tasks and function independently.
Detail-oriented with strong organizational skills.
Proficient in Microsoft Office (Excel, Word), Electronic Data Capture, and web-based software.
Excellent written and verbal communication skills.

Preferred Skills

Advanced degree in Life Sciences (e.g., PharmD, PhD, MSN, MPH) is highly preferred.
Experience in oncology or early-stage clinical development.

Additional Information

Planet Pharma is an equal opportunity employer, committed to diversity, equity, and inclusion.

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Clinical Development Scientist

Job Description

Job Overview

Key Responsibilities

Required Qualifications

Preferred Skills

Additional Information

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