Clinical Research Manager

Sirtex Medical – Woburn, MA

The Clinical Research Manager is an individual who takes a lead role within Clinical Operations in the coordination and implementation of clinical IDE studies, Investigator Initiated studies and Registries. This individual may provide guidance and direction to other clinical team members of other business unit as required by the Manager of Regional Clinical Operations.

Responsibilities/Authorities

Manages all clinical site aspects of study including:

  • 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 assist MRCO with vendor selection and contracting
  • Oversee the operations and finance 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
  • Undergo all formal Training Events as may be Directed from time to time
  • Observe and Comply with all Sirtex Corporate Policies
  • Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System
  • Education, Prerequisites and Skill Requirements

  • Bachelors degree or equivalent required
  • Minimum of 5 years of clinical study experience with on-site management responsibility
  • At least 2 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
  • Also requires excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team building skills
  • There is an expectation of study related travel for this role, within the country of residence and abroad. The percentage of travel will fluctuate according to the business need it will be no more than 50% at the highest level of need but likely to be 10-30% on a regular basis. These figures may be different based on the country of residence of the individual Clinical Research Manager.

    Training Requirements

  • Training and certification in ISO 14155; keep updated with changes to EU Directives, ICH GCP Guidelines as ongoing training
  • Training in Sirtex Quality System procedures, work instructions and other Quality System requirements
  • This job posting is no longer available on OPTnation.
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