- Managing vendors/CROs for assigned trials ensuring adherence to defined scope of work and budget
- Developing and maintaining tracking tools for clinical trials including sample tracking, study and monitoring visits, data entry and action item progress
- Working with financial management to reconcile monthly actual and forecast budgets
- Monitoring and/or co-monitoring clinical trial sites
- Planning and coordinating advisory boards, investigator meetings and CRA trainings
- Minimum 6 years' relevant industry experience including at least 5 years of trial management experience
- 3+ years' oncology or gene therapy experience
- Ability to contribute technical expertise to the various aspects of the clinical trial process
- Knowledge of the infrastructure and operational characteristics of CROs and centralized services as well as industry standards as applied to ICH guidelines, GCPs and the CFR
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Senior Clinical Trial Manager - Waltham, United States - Meet
Description
Senior Clinical Trial Manager - Oncology OR Gene Therapy experience REQUIRED
Exciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or CTM (based on experience) motivated by science and excited to work in a biotech focused on oncology and genetically driven disease.
Job Description
The Sr. CTM will be responsible for managing one or more clinical trials. This individual will ensure that project milestones delivery on time, within budget, high quality, and in compliance adhere to best practices.
Responsibilities
Skills Required
