Clinical Trial Manager

Responsibilities

• Lead for the end-to-end clinical trial delivery
• Manage trial start-up, conduct, and close-out activities according to industry and corporate standards with Director support
• Manage clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)
• Prepare key clinical documents (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, annual reports, etc.)
• Establish professional rapport and engage in frequent communication with investigational site personnel in order to keep study on-track
• Track internal metrics, timelines and budgets
• Communicate trial status to trial cross functional team
• Prepare and present trial specific metrics and updates to Director, Program Managers and Senior Management
• Participate in monitoring activities at clinical trial sites to assure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols and ensure that data is complete and accurate
• In conjunction with data management personnel, gain understanding of planning, monitoring, and executing data analyses
• Support applications and technical files as needed
• Collaborate with project specific committees (e.g., DSMB, CEC)
• Assist with preparation for investigators’ meetings
• Work with vendors as needed
• Travel up to 25% of the time

Qualifications

• 7+ years of CRA, CTA or equivalent, with medical device experience
• CTM experience preferred
• Bachelor's degree in Science, Life Sciences or relevant field; or equivalent combination of education and experience
• Experience interacting with sites, monitors, IRB’s, sponsors, vendors, clinical centers, and FDA
• Knowledge of adverse event investigation, analysis and reporting procedures and standards
• Proficiency with electronic data management systems
• Familiarity with clinical budget planning and management
• Coordinating external and internal documentation for clinical trials
• Understanding of data collection methodologies
• Familiarity with GCP, ICH, ISO and FDA regulatory requirements
• Ability to coordinate multi-center global clinical trials
• Willingness to be held accountable for deliverables
• Highly organized and detail oriented
• Results-driven and exhibits a sense of urgency
• Clear and concise in verbal and written communication
• Builds collaborative relationships both internally and externally

Benefits

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare
• Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

Pay

The expected base salary range for this role is $112,400.00 – $140,200.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location.