Clinical Trial Manager I

Acambis is a leading biotechnology company targeting infectious diseases with novel vaccines. Its headquarters are in Cambridge, UK, and it has operations in Cambridge and Canton, MA, and in Rockville, MD.

 

Acambis’ development-stage pipeline includes an investigational vaccine against Japanese encephalitis, ChimeriVax-JE, which is undergoing Phase 3 clinical testing, ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing and is the most advanced investigational vaccine against the West Nile virus, and the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. Acambis is recognised internationally as the leading producer of smallpox vaccines, which it manufactures for emergency-use stockpiles for the US Government and other governments around the world.

 

Acambis is listed on the London Stock Exchange (ACM).

 

The Cambridge office is looking for a Clinical Trial Manager Level I (CTM-I), who will assist with the management of Phase I-IV clinical studies that are designed to establish the safety and effectiveness of Acambis’ products. The CTM-I generally work independently on routine assignments, but may be more closely supervised on new or complex assignments. This position also works on studies of moderate scope, and exercises judgment within defined practices and policies to determine the appropriate course o f action to ensure study data delivery and progress. This position will report to the Clinical Program Manger, Clinical Operations.

 Job Responsibilities:

· Participate in the development of clinical protocols, Investigator’s Brochures, information/consent forms, training material, planning investigator meetings, case report forms, diary cards, clinical study reports and other clinical documents, as required by the project.

· Assists in managing resources to conduct clinical trials, including Contract Research Organization and consultants.  This includes learning how to define project specifications, evaluate and negotiate with potential providers and develop monitoring experience on an ongoing basis.

· Maintains study timelines. Report on study progress, including identification of problems and raising them to the next level as appropriate.

· Effectively prioritizes work and schedule to complete clinical study tasks and meet timelines.

· Begins to develop relationships with internal and external team members to achieve project goals.

· Assists with department administrative functions including filing and organization of project files, study files and assisting with the development of SOP’s.

· Demonstrates a general knowledge of clinical study design, clinical monitoring, project management, regulatory and safety considerations of clinical trials, etc., and continues to develop a greater understanding and how best to incorporate the knowledge gained. 

· Provide support for Clinical Operations, as required. This could include writing and reviewing department and company SOPs, maintain files, contribute to regulatory filings, etc.

· Other duties, as assigned.

 

 

 

The right individual needs a BA/BSc degree in biological science, nursing, pharmacy or equivalent, advanced degree optional, with a minimum of 2 years experience in the industry. Previous experience is required in conduct of clinical trials (e.g., Clinical Research Associate, or Clinical Trial Coordinator). Training and experience in applicable regulatory guidelines, including but not limited to: Good Clinical Practices, Good Manufacturing Practice, and Code of Federal Regulations are preferred, as well as an understanding of the technical and regulatory issues relating to the development of vaccines. High attention to detail with good interpersonal, organization and communication skills are a plus.

 

 

 

 

CONTACT INFO:

 

Human Resources

Acambis Inc.

38 Sidney Street

Cambridge, MA  02139

E-mail:  careers@acambis.com

Interested applicants must apply on-line attaching a word document to your email submission

 

Acambis Inc. provides a competitive salary and a full range of benefits.

We are proud to be an equal opportunity employer, dedicated to promoting a culturally diverse workplace.