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Job type: Permanent

Discipline: Clinical Research Associate (CRA), CRA Manager, Program Manager / Director

Location: United States

Proclinical is currently recruiting for an AD/Director of Clinical Research with a leading biopharmaceutical company located remotely. As the Direct of Clinical Research, you will be responsible for the generation of key study documents and the medical oversight of clinical study conduct in collaboration with Clinical Operations and other departments in the Development Organization under the direction of Clinical Research management

Job Responsibilities:

Develop, author, and execute on study protocols and amendments by investigating the literature, searching databases and other existing/investigational products, working with key opinion leaders, clinical trial investigators, and internal scientific, pharmacology and regulatory teams.
Review the data generated during the execution of a study to gather a medical understanding of the safety and efficacy results. Perform the role of Medical Monitor for one or more studies.
Present results to Safety Monitoring Committee and other internal and external meetings.
In collaboration with medical writing and biostatistics, contribute to the drafting of clinical study reports and other documents reporting data. Participate in the ongoing data reviews.
Provide medical insight to the draft responses to regulatory agencies and IRBs/ECs.
Liaise with Medical Information to provide results that will warrant Q&A updates.
Build and maintain a good knowledge of the existing data for our product and the literature about the target disease. Be aware the publications on competitive products.
Perform any other assigned task as requested by management.
Perform all responsibilities in compliance with company SOPs.

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or m.jacobs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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