What are the responsibilities and job description for the Clinical Trials Management Associate - III position at The Fountain Group?
Pay : $62.98
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
Knowledge & Other Requirements
Salary : $63
