Senior Clinical Research Manager

Sirtex • Woburn, MA

7h • $159,153 - $198,941

About The Position

The Senior Clinical Research Manager is an individual who takes a lead role within Clinical Operations in the coordination and implementation of clinical IDE-FDA studies, Investigator Initiated studies and Registries.
The Senior Clinical Research Manager is responsible for the implementation and management of Sirtex Technology Pty Ltd and Sirtex Medical clinical research activities in the region, including both pre- and post-marketing clinical trials with Sirtex’s lead product SIR-Spheres microspheres, and new device and drug products that Sirtex will develop in the future. This includes the development of detailed project plans and the identification of appropriate timelines, milestones and the budget and staffing resources required to ensure that the critical clinical trial projects are met. Key interactions include collaborations with the Medical Affairs, Commercial team, Health Economics, Biostatistician, Quality and Regulatory Affairs as well as Physician Investigators and appropriate medical and scientific research organizations.
In order to execute these responsibilities, the Senior Clinical Research Manager will support managing and developing the regional Sirtex clinical research staff, contract research organizations (CROs) and investigational site activities for which Sirtex is responsible in the region. The individual in the role will also be responsible for participating in the development of processes, implementing and maintaining departmental policies, procedures, and strategies to ensure that trials are performed in accordance with Good Clinical Practices (GCP).

Requirements

• Bachelor’s degree required or Master’s preferred
• Minimum of 6-8 years of clinical study experience with on-site management responsibility
• Experience leading IDE studies is required
• At least 4 years of monitoring experience in pharmaceutical, medical device, bio- technology or CRO companies required
• Understanding of ISO 14155 and fully conversant with ICH GCP guidelines, EU Directives and regulatory requirements
• Strong clinical study management skills including management of vendors at site level
• Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team building skills

Responsibilities

• Coordinates the study contract and budget process with sites, investigators, and required Sirtex personnel
• Creates and manages the internal study plans and timelines
• Provide study-specific training and leadership to clinical research staff, Clinical Research Organization (CRO), Clinical Research Associates (CRA), sites and other contract personnel
• May conduct initiation meetings, site selection visits, routine monitoring visits, and close-out visits, as well as assist in the organization of investigator's meetings and vendor kick-off meetings as appropriate
• Track study progress and ensure data integrity including providing status updates to the clinical team and clinical senior management
• Ensure all monitoring visit reports are completed in a timely manner
• Ensure all study documentation and contracts are complete and filed
• Assess clinical trial vendors and support with vendor selection and contracting
• Oversee the operations and support financial budgets of clinical trial vendors
• Track payments to clinical study sites and vendors in their region of responsibility.
• Act as liaison between internal departments, investigational sites, and vendors
• Ensure the completion of routine administrative duties such as arranging meetings and/or conferences, recording minutes, document copying and distribution and maintaining study files
• Ensure regulatory compliance of investigational sites with company Standard Operation Procedures (SOPs), Quality Work Instructions (QWIs), national and international regulations including EU Directives, ISO 14155. Compliance to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with the Study Management Team (SMT) and Health Economics to design clinical study protocols consistent with the clinical development initiatives to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met
• Prepare study-related documentation as necessary
• Provide input for the design of the Informed Consent Form (ICF), Case Report Forms (CRF), monitoring conventions, and edit checks, etc
• Develop relationships with investigators and site staff; select sites and countries (with Commercial input for pre- and post-marketing studies)
• Collaborate with the regional clinical team to develop and manage study budget and maintain budget within financial goal, when assigned
• Review clinical invoices against site contract and forward to Global Director of Clinical Operations for approval
• Ensure all clinical studies are executed in compliance with international ICH GCP guidelines/regulations, QWIs and ISO 14155 where appropriate
• Participates in the planning of quality assurance activities including preparation for audits and coordinating the resolution process to end point resolution of audit report observations and findings, including the coordination of the study documentation and central file reviews
• Review monitoring reports in a specified timeline manner to ensure quality and resolution of site-related issues
• Coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate
• Coach, mentor and provide guidance to the CTA and other junior Clinical Operations staff

Benefits

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level