Senior Clinical Trial Manager

Senior Clinical Trial Manager - Oncology OR Rare Disease 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 AD (based on experience) motivated by science and excited to work in a biotech focused on oncology and rare 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

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

Skills Required

Minimum 6 years’ relevant industry experience including at least 5 years of trial management experience

3+ years' oncology or rare disease 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