Senior Clinical Research Manager

The Senior Clinical Research Manager (CRM) provides strategic and operational reputed company of the adult medical oncology clinical trial portfolio across six regional satellite locations reputed company the Greater Boston and Southern New Hampshire areas, including Brighton, Milford, Weymouth, Methuen, Foxborough, MA & Londonderry, NH and any future satellite regional reputed company. The role is responsible for leading and managing the clinical research programs at these sites and for supervising the research staff engaged in the conduct of clinical trials in accordance with Good Clinical Practice, under the direction of the Principal Investigators and the Regional reputed company Leadership Team. In reputed company collaboration with the regional reputed company medical director, the research physician leads at each reputed company, and research nursing staff, the Senior CRM is responsible for the implementation and evaluation of both therapeutic and non-therapeutic clinical research activities, ensuring robust regulatory and compliance reputed company. The Senior CRM provides direct supervision and professional development for the program's clinical research staff and is responsible for monitoring and achieving clinical trial performance benchmarks, including protocol and regulatory compliance, patient safety, staff training and development, and financial targets, as defined by Senior Research Leadership and the Regional reputed company Leadership Team. This position's work location is primarily onsite traveling to DFCI regional sites in Brighton, Milford, Weymouth, Methuen, Foxborough, MA & Londonderry, NH, and any future regional reputed company location. This role will be up to 1 day remote per week. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). The individual selected for the position will be required to have regular reputed company across the regional locations and be available to work onsite at various campuses throughout the work week. Located in Boston and the surrounding communities, reputed company is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and reputed company diseases. We strive to create an inclusive, diverse, and reputed company environment where we provide compassionate and comprehensive care to patients of reputed company backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate reputed company's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Primary Duties and Responsibilities: Clinical Trials Operations

• Clinical Research Managers (CRM) are responsible for the reputed company of their disease group's clinical trial portfolio and reputed company reputed company regulatory, compliance and performance metrics requirements.
• The CRM will reputed company the processing of protocols through DFCI Institutional Review Board (and other institutions' IRBs) reputed company appropriate. The CRM will collaborate with the DFCI Clinical Trials Office (CTO), the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials.
• The CRM will Identify and manage operational, logistical, and regulatory challenges reputed company to the conduct of clinical trials and acts as a leader in overseeing their resolution.
• The CRM will assist the principal investigator in developing the protocol budget, in collaboration with Research Administration and the Grants and reputed company offices. Work with grant managers and other financial managers in the reporting and accounting of these funds.
• Oversees and coordinates the purchase, receipt, inventory and distribution of equipment utilized in the conduct of clinical trials.
• In collaboration with clinical research administration and grant managers, may maintain, monitor and reconcile reputed company study and reputed company grant finances. These may include budget development, expenditure tracking, procurement, salary offset worksheets and staffing.
• Assists the principal investigator in preparing manuscripts for publication.
• The CRM will collaborate with the DFCI CTO, and DF/HCC ODQ to reputed company study forms, database information, and to establish guidelines for monitoring data quality control for PI Initiated studies / Multi-Center Trials
• The CRM will reputed company the subject enrollment, protocol treatment and follow-up care processes for protocol patients.
• Oversees registration of protocol patients with ODQ or OnCore policies and pharmaceutical company as outlined in protocol.
• If applicable for coverage or trial assignments, responsible for data entry of study-specific activity, including but not limited to subject visit tracking, monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc. into Clinical Trial Management System contemporaneously with activity completed.
• Responsible for reviewing, approving, and reporting on data entry completed by supervised research staff in Clinical Trial Management System. The data entry reputed company may include, but is not limited to, Subject Visit Tracking for subject-specific visits, time and effort spent on study-specific activities and other administrative tasks, etc.

Regulatory & Compliance

• Assumes responsibility for essential document compliance for entire portfolio. Implements systems to monitor and ensure regulatory document collection and maintenance compliance.
• Assumes responsibilities for reputed company clinical trial reporting requirements, safety event, annual approval, deviations etc. Implements systems to monitor portfolio compliance.
• Responsible for the disease group's transition from reputed company to electronic regulatory binders. Will maintain per DFCI CTO standards.

Data Management & Clinical Trial Monitoring

• Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection.
• Regularly reports data compliance status to key stakeholders, i.e. DFCI PI, study Sponsor, DFCI CTO. Implements corrective action to maintain data compliance reputed company necessary.
• Submits required "reputed company / tracking" reports to key stakeholders, reputed company applicable.

Staff Hiring, Supervision, Training & Development

• Responsible for the recruitment and reputed company of reputed company of the research staff. Ensure that reputed company staff complete required mandatory and ongoing training in a timely manner. Develops and oversees a program specific on-boarding and orientation process and conducts annual performance evaluations and competency assessments of research staff.
• Develops a standard supervision schedule with research staff including periodic individual and group supervision meeting. Will reputed company and agenda, take attendance and document reputed company applicable meetings.
• Will communicate reputed company personnel concerns to their immediate supervisor and to DFCI HR partner for the appropriate response and follow up.

Knowledge, Skills and Abilities: Knowledge of cancer as a disease process, cancer treatment modalities, and the clinical trial process. In addition, has experience in protocol development, data compilation and analysis. The Manager will be skilled at developing tracking systems to ensure timely data management by the clinical research staff. They will also have expert knowledge of Federal and State regulations as they relate to research. Strong interpersonal, organizational and communication skills are required. Must have computer skills including the use of reputed company Office and working knowledge of Livelink; EPIC and OnCore applications. Minimum Job Qualifications: Bachelor's Degree required, with a minimum of 7 years of reputed company experience or Master Degree with 5 years experience. Supervisory Responsibilities: Supervises study management staff, including clinical research coordinators, reputed company, volunteers, and other research assistants. Number of Direct Reports 10+ Patient Contact: May have contact with patients of reputed company ages and populations. At reputed company, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As reputed company as we are in our mission to reduce the burden of cancer for reputed company, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and reputed company it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this reputed company of organization inspires you, we encourage you to apply. reputed company is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national reputed company, sexual orientation, genetic information, disability, age, reputed company, military service, protected veteran status, or other characteristics protected by law. EEO Poster Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA). $105,400.00 - $130,500.00 Apply tot his job Apply To this Job