Duration: 6 months
Job Description:
Provide clinical development support across late-stage program(s), with a focus on generation, review, and interpretation of clinical data and preparation of clinical documents. Work closely with internal clinical development team members, biometrics, regulatory, pharmacovigilance, and CRO partners to support execution and reporting of clinical trials and related regulatory deliverables.
Responsibilities
Clinical Development & Program Support:
Provide scientific and clinical input across the program, collaborating with internal team members and CRO partners.
Support review and interpretation of clinical trial data to inform program decisions and regulatory documentation.
Participate in cross-functional clinical development meetings and contribute to program strategy discussions as needed.
Data Review and Analysis:- Review and interpret clinical trial data, including tables, listings, and figures.
- Support data cleaning activities, medical data review, and issue resolution in collaboration with CROs and internal teams.
- Contribute to analyses of safety and efficacy data, including post hoc and exploratory analyses as appropriate.
- Regulatory and Clinical Documentation
- Contribute to authoring, reviewing, and finalizing key clinical and regulatory documents for regulatory activities, including but not limited to:
- Clinical Study Reports (CSRs)
- Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy
- Investigator’s Brochure (IB) updatesDSURs and other compound level safety documents
- Clinical sections of regulatory submissions and related briefing documents
- Draft and/or review study level narratives and support narrative review for submission readiness.
- Study Design and Conduct
- Contribute to development, review, and amendment of clinical trial documents, including:
- Protocols and protocol amendments
- Informed consent documents
- Statistical analysis plans (in collaboration with Biometrics)
- Clinical trial plans and other supporting documentation
- Provide clinical input into study conduct questions and protocol interpretation during trial execution.
- CRO and Vendor Interaction
- Serve as a clinical development point of contact for CROs and external vendors.
- Participate in regular meetings with CRO teams to address protocol related questions, data review issues, and trial conduct topics.
- Support oversight of CRO deliverables related to clinical data, reports, and submission documents.
Safety and Pharmacovigilance Collaboration:
Participate in Safety Review Team meetings and routine interactions with Pharmacovigilance as needed.
Review safety data and support evaluation of emerging safety signals in collaboration with safety colleagues.
Contribute clinical input to safety-related documents and benefit-risk assessments.
Additional Responsibilities:
Support preparation and review of compound-wide and cross-program documents as needed. Provide ad hoc clinical development support to address regulatory, internal review, or inspection readiness activities as needed.
Experience:
Physician with at least 5 years of drug development experience.
Experience with Nephrology and/or immunology preferred.
Skillsets:
Proficiency in clinical data review and interpretation.
Experience in authoring and reviewing clinical and regulatory documents.
Ability to collaborate with cross-functional teams and CRO partners.
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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