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Clinical Operations Manager Enanta Pharmaceuticals
DescriptionThe Clinical Operations (ClinOps) Manager is responsible for the successful execution of clinical trials from the protocol concept through clinical study report, ensuring high quality and timeliness of clinical trials.
Qualifications
The candidate must have a degree (B.S, MS or PhD) in a biological or medical/nursing field. Experience in clinical monitoring and clinical operations management is preferred. Additional experience in project management is a plus. He or she should have strong knowledge of GCP?s and FDA regulations.
Responsibilities
Site selection, training and performance management
Liaison with sites and CROs
Negotiation of contracts
Develop and manage budgets and payments
Oversight of clinical monitoring at sites
Implement strategies for patient/subject enrollment
Track enrollment and key patient data
Prepare reports for senior management
Ensure GCP compliance
Development of protocols, informed consent documents, CRFs
Participate in preparation of study reports and regulatory submissions
Investigator meeting management
Timeline management
Excellent communication skills
Good reasoning ability
Skills to work with external consultants, investigators, site staff and CROs
Basic knowledge of pharmacology and medical science
Skills
Excellent communication skills
Good reasoning ability
Skills to work with external consultants, investigators, site staff and CROs
Basic knowledge of pharmacology and medical science
| Location: | 500 Arsenal Street Watertown, MA 02472 United States |
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Enanta Pharmaceuticals
Investors: BioVentures Investors, Oxford Bioscience Partners, TVM CapitalAll Jobs: at Enanta Pharmaceuticals
| Web Site: | www.enanta.com |
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| Headquarters: | 500 Arsenal Street Watertown, MA 02472 United States |
| Industry: | Biotechnology |
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