Job Title: Clinical Trials Manager
Job Number: 24697
In this Clinical Operations role, the Clinical Trial Manager is responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. This position will report to the Head of Clinical Operations and reside in our Boston, MA office.
Duties & Responsibilities
The successful candidate will:
- Assist with the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
- Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelines.
- Work closely with the Program Lead to coordinate, track, and manage all logistics in support of the clinical Program
- Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the Program Lead and Finance.
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Assist with authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
- Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
- Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
- Assists with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations.
Qualifications & Skills
Education and Experience:
- BA/BS in a scientific field of study with 3-5 years progressive experience in clinical operations.
- Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
- Ability to handle a high volume of highly complex tasks within a given timeline.
- Ability to lead a cross-functional team in a matrix environment
- Experience managing clinical programs, CROs, budgets, and timelines required
- Strong working knowledge of MS Project and developing Gantt charts
- Excellent interpersonal and negotiation skills
- Strong verbal and written communication and presentation skills
- Travel up to 20%