Clinical Research Manager (Remote in Eastern/Central Time Zone)
Posted Date: 03/16/2023
If you’re looking for a patient-focused, innovation-driven company that will inspire you, we invite you to apply. Join us as our Clinical Research Manager (Remote). This position must reside in either the Central or Eastern time zone(s).
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 experience Clinical Research Manager to help us with our growth.
At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions.
Here, you will be a vital contributor to our inspiring and bold mission.
How you will contribute…
As a Clinical Research Manager, you’ll be empowered to work for the Senior Clinical Operations Manager who enthusiastically supports professional growth. The Clinical Research Manager takes a lead role within Clinical Operations in the coordination and implementation of clinical Investigation Device Experts (IDE) -FDA studies, Investigator Initiated Studies (IIS) and Registries. You will provide guidance and direction to other clinical team members of other business units too. You’ll manage all clinical site aspects of the study including:
- Leading internal/external study team meetings; collaborating with the cross functional team to manage study progress and issues, identifying potential risk, and proposing mitigation strategies. Act as liaison between internal departments, investigational sites, and vendors
- Effectively managing the assigned study plans to ensure that deliverables are met within established timelines, budget, and quality standards
- Providing study-specific training and leadership to clinical research staff, Clinical Research Organization (CRO), Clinical Research Associates (CRA), sites and other contract personnel
- Conducting initiation meetings, site selection visits, routine monitoring visits, and close-out visits, as well as assisting in the organization of investigator's meetings and vendor kick-off meeting. Ensuring the completion of routine administrative duties such as arranging meetings and/or conferences, recording minutes, document copying and distribution and maintaining study files
- Coordinating the study contract and budget process with sites, investigators, and Sirtex personnel
- Tracking study progress and ensuring data integrity including providing status updates to the clinical team and clinical senior management
- Ensuring all study documentation and contracts are complete and filed
- Assessing clinical trial vendors and assisting with vendor selection and contracting
- Overseeing the operations and finance of clinical trial vendors including tracking payments to clinical study sites and vendors.
- Ensuring 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
- Working 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
- Providing input for the design of the Informed Consent Form (ICF), Case Report Forms (CRF), monitoring conventions, and edit checks, etc
- Developing strong relationships with investigators and site staff; select sites and countries (with Commercial input for pre- and post-marketing studies)
- Ensuring all clinical studies are executed in compliance with international ICH GCP guidelines/regulations, QWIs and ISO 14155
- Participating 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
- Coordinating and assisting in the planning of regulatory or ethics committee activities
- Coaching, mentoring and providing guidance whenever possible.
The following skills, experience and traits are needed…
- BS degree within a scientific discipline is required or international equivalent. Advanced degree(s) (i.e. Master’s, RN, Doctorate) may be considered to supplement experience requirements
- 6+ years of clinical study management experience in the medical device, pharmaceutical, biotech or clinical research organization required
- Previous experience with regulatory in the EU required as this role will support EU clinical trials activities.
- Previous experience with clinical research projects of varying kinds.
- Understanding of ISO 14155 and fully conversant with ICH GCP guidelines preferred.
- Strong clinical study management skills including management of vendors at site level is required
- Therapeutic or medical knowledge in Oncology Research preferred
- Familiarity with multinational regulations preferred
- Personable, energetic, responsive, confident, and honest. Sense of humor is always welcome.
- Strong organization and time management skills.
- Self-starter and the ability to work as part of a team.
- Strong verbal, written, analytical, and persuasive skills and ability to interact effectively with all levels.
- Strong interpersonal skills, an energetic, proactive, flexible individual with high integrity and ethics in all dealings.
- Eager to learn, enthused by the day and resilient with a sense of humor.
- Basic office computer skills (email, word processing, and spreadsheet software).
What you can expect from us…
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.
Our Equal Employment Opportunity (EEO) belief...
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 provide reasonable accommodation(s) 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.
Be part of an amazing team that is helping to save lives, every day.