Clinical Data Manager II

Proclinical is currently seeking a Clinical Data Manager for a biotechnology company located in Cambridge, MA. Successful candidate will be responsible for leading moderate complexity clinical studies from study start-up to close out according to the study protocols, standard operating procedures, and all applicable regulatory requirements.

Job Responsibilities

• Leading all the study-specific CDM tasks performed by the CROs for multiple moderate complexity studies.
• Forecasting timelines and resources required to complete study-specific tasks on time and with high quality.
• Leading execution of CDM tasks according to the agreed upon timelines, mitigating risks as appropriate.
• Delegating tasks to the CDM team members and vendors.
• Planning and facilitating internal and external study meetings.
• Collaborating with vendors and cross-functional teams to develop Data Transfer Specifications.
• Reviewing operational clinical study documentation including project timelines, meeting minutes, memos and study notes to file.
• Ensuring that delegated and outsourced tasks are performed according to quality standards.
• Performing all the data management tasks in support of Phase I - IV gene therapy clinical studies.
• Reviewing clinical protocols and providing input.
• Leading eCRF design and Data Validation specifications programming.

Skills and Requirements

• Bachelor's degree, preferably in health science or related field.
• In-depth CDM knowledge and basic understanding of related Clinical Development functions.
• Ability to solve complex problems and takes a broad perspective to identify solutions and best practices.
• Works independently, seeking guidance in unique and complex situations.
• Proven ability to successfully design, lead and execute CDM initiatives with a clear positive impact on organizational goals.
• Must be able to work in a fast-paced environment with changing priorities and deadlines.
• Highly organized and detail oriented.
• Strong EDC skills, including Medidata Rave and IBM Health.
• Therapeutic Area knowledge.
• CDISC knowledge.
• Project management and delegation skills.
• Strong 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 Junis Citozi at (+1) 929-388-1650 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.

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