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Job Description

Sr. Clinical Project Manager

Region: Americas
Location: Remote

Posted Date: 08/17/2022

Who We Are

Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast growing; dynamic organization and we seek an experienced Sr. Clinical Project Manager to help us with our growth.

What You'll Do

The Sr. Clinical Project Manager is responsible for leading and managing the cross functional study team and is accountable for the operational delivery of one or more clinical studies from study concept through clinical study report (CSR). S/he is responsible for developing clinical study timelines and budgets and leading operational planning, proactive risk management and execution of clinical studies according to time, cost and quality targets. S/he is responsible for oversight of all study activities and escalates issues when needed from study concept through finalization of clinical study reports. S/he will collaborate with cross functional teams to execute clinical study protocols, develop project and study management plans while adhering to budget, scope and schedule requirements. S/he will develop study performance matrix and management plans. S/he will manage the project activities including but not limited to clinical monitoring, data management, statistical analysis, medical writing, safety monitoring and compliance to insure proper conduct and timely completion of all projects. In this role you will:

  • Report to the Global Director, PMO
  • Ensure that the Trial Master File (TMF) is set up and maintained throughout the trial in compliance with ICH/GCP and company SOPs, including conducting periodic reviews to ensure all appropriate documents are filed.
  • Manage all clinical aspects of the clinical project including:
    • Plan, execute and manage all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets timelines and corporate goals.
  • Lead the study team to manage risk mitigation strategies including (but not limited to):
    • Identify study level risks
    • Develop, maintain, and implement risk mitigation and contingency plans
    • Ensure key functional lines and senior management are informed of study level major risks and contingency/mitigation plans
    • Monitor progress against study plan and develop and implement operations risk management plans across the project
  • Accountable for vendor oversight including (but not limited to):
    • Determine study requirements, define specifications/scope of work, and initiate and lead the selection of vendors
    • Manage financial aspects for clinical vendors
    • Manage and oversee CRO and clinical vendor relationship and activities; implement plans for efficient and effective vendor oversight
  • Lead the development, review and approval of all study documents including (but not limited to) the following study-specific strategy tools and processes:
    • Study timeline and budget
    • Risk management plans
    • Investigator/site/country/patient recruitment plans
    • Request for proposal [RFP] process for clinical vendors
    • Vendor specifications, management plan and oversight
    • Communication plans (including site and sponsor communication, vendor communication as well as site escalation)
    • Ongoing data review plans
    • Educational/training plans
    • Performance and compliance metrics
  • Contribute to the development, review and approval (when appropriate) of all study documents and tools including (but not limited to):
    • Clinical protocols and amendments
    • Informed consent templates
    • Site feasibility questionnaires
    • Case report forms [CRFs] and CRF guidelines
    • Trial master file plan
    • Data / integrated voice recognition system [IVRS] management plans
    • Pharmacy brochures, and regulatory binders
    • Data monitoring committee charters
    • Clinical study reports
  • Collaborate with Legal department and/or clinical research organizations [CROs] to ensure timely review of the confidential disclosure agreements [CDAs] and clinical trial agreements [CTAs]
  • Manage clinical program/study budgets in conjunction with function heads and Finance
  • Represent clinical study team for study planning and maintenance activities with external vendors
  • Support selected investigative sites for IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with Legal and CROs
  • Manage and resolve study conduct issues (including protocol deviations, data queries, SAEs/AEs, laboratory discrepancies, and archive reconciliation activities) as applicable.
  • Plan, execute, and lead study-specific meetings (e.g., cross-functional clinical development team, investigator meetings, advisory committee, etc.)
  • Communicate clinical study performance
  • Manage clinical study budget within agreed variance
  • Provide study-specific training and leadership to internal staff, CRO, sites, and other contract personnel
  • Prepare and present project debriefings, as required.
    • Ensure adequate follow-up with investigative sites as needed to ensure the identified study conduct issues are resolved and reconciled. Participate in and lead departmental initiatives as requested.
  • Contribute to SOP development

Who You’ll Be

  • Bachelor's degree in health sciences or related field required. Advanced degree preferred.
  • Minimum of 8+ years' experience in global clinical trials and 3-5 years of project management.
  • Experience in management of CROs, vendors and consultants.
  • Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines in clinical trials required.
  • Demonstrated project management and leadership experience. Proven track record for delivering quality multi-center global clinical projects on time and within budget.
  • Proficient written & verbal communication and presentation skills.
  • Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
  • Therapeutic or medical device knowledge preferred.
  • Strong computer skills including knowledge of MS Project, Excel, Word, PowerPoint and Outlook.
  • Position may require some travel.
  • Bilingual, Mandarin (Chinese) speaking is preferred

What You Can Expect from Sirtex:

If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
  • A working culture of respect, diversity, and performance to help facilitate an inclusive culture
  • Attractive compensation and benefit packages which are practical, robust, fair and equitable
  • A place to grow through career development and training opportunities
  • Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world.

Conditions of Employment

  • Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations.
  • Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.

Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments.  We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.                                                                                                   

Apply Now!   

Be part of an amazing team that is helping to save lives, every day.