Clinical Trials Manager
4 days ago
Duration: 12 months contract
Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.
Description:
- Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of products.
- You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase I studies or other smaller studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives.
Responsibilities:
- Manages all components of small clinical studies, including Phase I studies.
- Typically serves as the key operational contact for studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.
- Defines and develops the study logistics and clinical study plan for assigned clinical studies.
- Manages study timelines, including documentation and communications.
- Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
- Contributes to SOP development and/or participates in special projects.
- Develops tools and processes that optimize project efficiencies and effectiveness.
- Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
- Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
- May be required to present at internal or external meetings (i.e., investigator meetings).
- Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
- Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
Minimum Education & Experience
- PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.
- MA / MS with 3+ years’ relevant clinical or related experience in life sciences.
- BA / BS / RN with 5+ years’ relevant clinical or related experience in life sciences.
- Extensive oncology (preferably solid tumours) experience
- Experience in Primary Analysis and data analysis in general
- Familiar with PFS and OS analysis, imaging management in oncology Clinical trials, ePRO management
About US Tech Solutions:
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, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Ajit
Email: ajit.kumar@ustechsolutionsinc.com
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