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Celgene Corporation

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide.At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.There are more than 300 clinical trials at major medical c... Read More

Address      86 Morris Avenue Summit, NJ 07901
Website      www.celgene.com
Holding      No Holding Details

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Clinical Trial Associate

Degree in relevant discipline, or equivalent

2 years experience as CTA or comparable operating experience in Pharma/CRO/Healthcare

Valid Swiss working permission or EU Citizenship required

Summary/Scope:

- The Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team, supporting the Study Team by creating and distributing study team materials, tools and documents.

Responsibilities include, but are not limited to:

- Support the Study Team to select potential investigators and assess their interest in the study
- Communicate with the sites through direct contact and other tools such as newsletters as appropriate per study requirements
- Track study progress in CTMS including patient enrollment and patient status
- Process drug shipments after gathering necessary essential documents and track the receipt of shipments
- Support study data as the EDC administrator and by tracking CRFs and queries as appropriate
- Process and track payments to vendors and study sites as appropriate
- Have a significant role in managing the study documentation including responsibility for: •
- Distribute and, at times, create study documents for the study sites such as CDAs, feasibility questionnaires, study binders, etc •
- Review documents including essential documents and submit documents to appropriate departments such as IMSC, Regulatory Affairs, etc •
- Maintain and track documents such as IB, insurance policies, documents that are expiring and IND safety letters using CTMS (or other tools) •
- Support the Study Manager in creating, updating and tracking MS Project study plans •
- Collecting, quality review and submitting documents to the TMF •
- Performing QC of TMF as appropriate •
- Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors •
- Generate, finalize and distribute study team agendas and meeting minutes •
- Assist with generating the CSR appendices and participate in SOP and WP development •
- Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives

Skills/Knowledge Required:

- Computer skills - MS office suite
- CTMS (TW, Celtrak)
- Knowledge of databases
- Efficient at meeting planning / generating minutes
- Understanding / familiarity with drug development and process and Pharma
- Strong Verbal and written communications skills
- Self starter / proactive
- Ability to work independently
- Good listener / problem solver
- Ability to prioritize and multi-task and demonstrate flexibility and attention to detail
- Familiarity with ICH / GCP and regulatory guidelines/directives
- Team player and ability to build relationships
- Strong organizational skills
- Proficient at Vendor / site payment process
- Knowledge of medical/scientific terminology
- Cross cultural awareness

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

not provided

Contact Name:

not provided

Job Duration:

not provided

Phone:

1-908-673-9000

Email:

not provided

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