Senior Clinical Development Scientist

Proclinical, in support of our client, are seeking an individual to fill the role of Senior Clinical Development Scientist, based in Waltham, MA.

Responsibilities

• Contribute to protocols, clinical study reports, IBS, ICFS, training documents, CRFS and other clinical and regulatory documents.
• Contribute to clinical operations and data management in database development, data review and querying.
• May serve as a medical monitor for clinical trials of low complexity or provide support for medical monitoring activities on trials of increased complexity.
• Implement protocols regarding site identification and communication, attendance at investigator's meetings, correspondence with sites and interaction with operations teams.
• Interact with all of the disciplines necessary for successful study implementation.
• Compile data for efficacy and safety evaluation.
• Deliver enhanced efficiencies and quality around tactical deliverables, IND and other regulatory submissions, protocol development, amendments and all supporting documents, PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
• Prepare abstracts, posters, oral presentations, manuscripts and clinical study reports.
• Contribute to the preparation for development advisory boards, as needed.
• Represent the company at congresses and investigator meetings, as needed.

Skills and Qualifications

• Advanced Science/Clinical degree required and 4+ years of experience in clinical development, preferably in oncology and/or hematology.
• Experience in developing study protocols and conduct/reporting of clinical studies in accordance with ICH/GCP and other relevant guidelines and regulations.
• Experience with database development, design of data collection tools/reports, data review and querying.
• Excellent data analysis skills.
• Understanding of product and safety profiles.
• Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

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

#LI-KD1