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Senior Manager, Clinical Research Operations


Posted Friday, July 7, 2023

Posting ID: JP-003887906

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Boston, MA
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Principal Duties and Essential Functions 

• Manages day-to-day operations and is responsible for administrative aspects related to the Research center in collaboration with faculty directors 

• Responsible for clinical trial processes and provides support to the clinical research team, and provides escalation to the Faculty Director when appropriate.

• Works closely with PIs and study staff to assess feasibility of undertaking new projects or proposed protocols

• Facilitates a protocol review committee 

• Establishes, develops and maintains partnerships with industry sponsors, other hospital collaborators and clinical trials network professionals as appropriate.

• Maintains collaborative, team relationships with peers and colleagues to effectively contribute to goals, and to help foster a positive work environment; may serve on Research and Hospital-wide committees related to clinical research and/or process improvement, if necessary or desired.

• Is responsible for the overall supervision of clinical research staff including hiring, training, performance reviews and termination. 

• Is responsible for accurate and timely submission of IRB documents, data submission to the Clinical Trial Management System (CTMS) and data collection requirements for study sponsors.

• Develops and monitors budgets, including standardized processes for budget development and budget workbook preparation and charge code identification. 

• Serves as primary contact for study monitor and on-site audits. Is responsible for ensuring appropriate preparation of materials for these activities.

• Ensures compliance with all hospital, local, state, federal and sponsor guidelines and regulations that govern clinical research. Liaises with Compliance Officer and Research Administration to uphold regulations and report non-compliance. Works effectively to create and fulfill corrective action plans as necessary.

• Works closely and communicates continuously with clinical research team and providers to steward effective recruitment, enrollment and retention processes.

• Ensures investigational drugs are handled appropriately and curates a positive working relationship with the Investigational Drug Service.

• Conducts regular team meetings, 1:1 staff meetings, and monthly meetings with leadership to review status of clinical trials, assess workloads, report on budget, and flag areas for discussion or decision-making  

• Ensures completion of each study on time and on budget and supervises the curating and logging of all study monitor and audit follow-up reports

• Works collaboratively with Research Administration to facilitate budgetary discussions related to funding, staffing, and financial projections.

• Promotes a responsive and customer-oriented team in the research center.

• Performs other similar and related duties as required or directed.

Job Knowledge and Skills

• Strong interpersonal and management skills to interact with academic faculty, clinicians, and staff

• Ability to manage and adhere to clinical research protocols, principles, and procedures

• Ability to develop and monitor clinical trials budgets

• Ability to engage in budget negotiation, financial auditing

• Understanding of clinical research methods such as screening, interviewing, reviewing medical records, case report forms, etc.

• Must possess strong planning, problem-solving, analytical, organizational, project management skills 

• Outstanding oral/written communication skills 

• Capacity to adaptively manage relationships with a variety of individuals in differing roles

• Ability to anticipate programmatic needs and flag project risks to faculty leadership 

• Ability to delegate to others by setting priorities for completing multiple tasks

• Proficient with the Microsoft Office Suite (Excel, PowerPoint, and Word) and Adobe Acrobat; familiarity with Box, Microsoft Teams, and Sharepoint a plus 

• Ability to effectively handle multiple competing deadlines and shifting priorities

• Keen analytical skills; ability to identify, gather, manage, and synthesize relevant information to support data-driven decisions

• Ability to have discretion with sensitive information, including PHI and other confidential information complying with institutional data privacy policies and guidelines

Contact Information

Recruiter: Matthew Sherman

Phone: +17813566917


The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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clinical trials
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