Sirtex Medical Limited · 6 hours ago
Senior Clinical Research Manager
United States
Full-time
Remote
Senior Level
$159K/yr - $199K/yr
6+ years expSirtex Medical is a global leader in healthcare, dedicated to improving patient outcomes through innovative therapies. The Senior Clinical Research Manager will lead clinical operations, coordinating and implementing clinical studies and ensuring compliance with regulatory standards.
BiotechnologyHealth Care
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
Qualification
Required
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
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.
Company
Sirtex Medical Limited
Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.
201-500 employees
H1B Sponsorship
Sirtex Medical Limited has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (3)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2018-05-04Acquired
Leadership Team
Matt Schmidt
Chief Executive Officer
Francis Jannot
Executive Vice President International Commercial
Recent News
2025-09-09
Company data provided by crunchbase