Clinical Trials Management Associate
2 weeks ago
Sr. Clinical Trial Management Associate (Senior CTMA)
FUNCTION: Clinical Operations - Biomarker and Bioanalytical Operations
POSITION OVERVIEW:
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 support other Clinical Operations team members in the start-up, maintenance, and close-out of clinical studies.
You may manage certain components of clinical studies and act as a member of the study team. \
You may also manage vendors and/or manage investigator-sponsored research.
You may assist in the review of clinical study protocols and other study documents, contribute to SOP development and/or participate in special projects.
RESPONSIBILITIES:
• Leads or manage components of Phase I, II or III studies
• Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors.
• May assist as operational contact for Clients studies
• Plans and coordinates all operational activities required with the collection, delivery and analysis of biological samples within a clinical trial
• Manages study timelines, including documentation and communications
• Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in Client and Collaborative (CO) programs
• Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
• Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.
• Participates in the review and approval of main study and optional informed consents, and may review additional study specific informed consents
• Contributes to SOP development and/or participates in special projects
• Develops tools and processes that optimize project efficiencies and effectiveness.
• Proactively identifies potential operational challenges and collaborates with key stakeholders to provide solutions to ensure study execution remains on track to projected budgets and timelines.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
• MA/ MS / PharmD / PhD with 2 + years' relevant clinical or related experience in life sciences.
• BA / BS / RN with 4 +years' relevant clinical or related experience in life sciences.
• Experience in managing the work of external vendors.
• Meets all requirements for Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable proficiency.
Knowledge & Other Requirements
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