Clinical Trial Manager

Veristat•Massachusetts, MA

5d•$150,000 - $160,000•Remote

About The Position

The Clinical Trial Manager (CTM) provides operational expertise and leadership to multiple clinical trial teams, to ensure the effective and efficient delivery of all aspects of multiple studies, through all phases of clinical study management, in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and applicable local regulations.

Requirements

Bachelor’s Degree required; degrees in health sciences strongly preferred
5 or more years of experience as a CRA in a CRO or Pharmaceutical setting
Ability to effectively lead a project team required
Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment required
Excellent oral and written communication skills in English, including proficient presentation skills required
Proficient knowledge of study specific therapeutic area
Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint required
Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required
Ability to self-motivate, be a team player, and work independently
Excellent critical thinking and problem-solving skills required
Ability to self-motivate, work collaboratively within a team, proactively manage workload, and manage competing priorities in a fast-paced environment required

Nice To Haves

Ability to speak and write in other languages a plus

Responsibilities

Provides operational expertise and leadership to multiple clinical trial teams.
Ensures effective and efficient delivery of all aspects of multiple studies through all phases of clinical study management.
Adheres to applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions.
Complies with current Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and applicable local regulations.
Serves as a mentor, coach, and trainer for assigned CRAs.
Effectively supports and manages exchanges with external customers.
Provides appropriate input to study documents (e.g., protocols, CRFs, EDC development).
Self-motivates, works collaboratively within a team, proactively manages workload, and manages competing priorities in a fast-paced environment.