Actalent Clinical Trials Assistant in Durham, North Carolina
The Clinical Trials Assistant supports the global clinical development program for one or more product candidates, with one or more indications, from early development to regulatory approval and beyond, in order to achieve a high quality product for the marketplace and business success for company. Primary responsibilities follow:
Assist with managing internal resources, external partners, consultants, vendors and external budgets to ensure the timely and cost-effective implementation of the Clinical Development Plan for one or more global development programs.
Establish and maintain effective communication and collaboration with functional area peers, including regulatory, quality assurance, project management, as well as clinical investigators in order to meet program objectives and support achievement of department and corporate goals.
Implement and maintain internal processes and systems to support the efficient and high quality conduct of clinical trials including (where applicable) clinical trial management systems (CTMS) and trial master files (TMFs).
Clinical Support, Regulatory Documents, Site Communication, IRB
Additional Skills & Qualifications:
Administrative experience with a minimum of 2 years of pharmaceutical development experience gained ideally in a Sponsor and/or CRO role. Hands-on experience with supporting more than one clinical program. Knowledge of the pharmaceutical business, clinical trial planning and conduct. Additional requirements include strong organization and inter-personal skills and the ability to manage and cultivate relationships and the ability to communicate effectively internally and externally.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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