Senior Clinical Data Manager (Remote)
Posted Date: 10/17/2022
Who We Are
Sirtex Medical is a global healthcare business working to improve outcomes in people with cancer with offices in Boston, Sydney, Germany, and Singapore. 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 are a fast growing; dynamic organization and we hope you’ll join us. We are seeking a Senior Clinical Data Manager to work remotely.
What You’ll Do
As the Senior Clinical Data Manager, you'll lead all aspects of data management activities. You'll drive innovative digital and data strategies for projects and ensure timely and quality data to facilitate data analysis and reporting for studies and projects. You will support the Clinical Affairs/Biometrics team with clinical trials by leading biometrics data operations strategy through collaborations with colleagues across Sirtex. You will also develop biometrics data operation strategies, collaborate with colleagues, leveraging expertise in data management. This position reports to the Sr Principal Biostatistician. In this critical role, you'll:
- Lead all aspects of clinical data management (CDM) for multiple clinical studies (prospective trials, retrospective trials, registries, investigator-initiated studies) across multiple indications
- Provide inputs into protocols, study specifications, and selection of contract research organizations (CROs) and other vendors
- Attend and contribute to cross-functional meetings with medical affairs, publications, and health economics teams
- Ensure quality completion of your deliverables
- Maintain documents for Clinical Affairs team into document management systems
- Develop and present CDM activities during investigator meetings, CRA workshops, and project meetings as needed
- Monitor data quality and progress of trials both internally and at CROs with implementation of corrective actions when needed
- Develop and design electronic case report forms (eCRFs) in collaboration with internal clinical affairs teams and CROs
- Design, test, and validate study-specific electronic data capture system with CROs
- Develop programs to check the integrity of clinical data (range, error, and logic checks)
- Assist study sites with electronic data capture (EDC) system questions and issues
- Ensure integration and regulation of third-party and non-CRF data as applicable
- Ensure complete knowledge and implementation of medical term coding with medical teams using standard dictionaries
- Ensure consistent checks of serious adverse events data across clinical and device safety databases
- Act as a project lead through clinical affairs/biometrics meeting by presenting on status of study, proactively identifying and mitigating risks to ensure timely database locks after clinical studies
- Escalate issues to biometrics leadership about risks and challenges and solutions, as appropriate
- Support biometrics leadership to initiate, drive, and implement innovative digital and data strategies, development of dashboards across clinical studies in order to present to both internal and external stakeholders
- Have an in depth understanding of Good Clinical Data Management Practice guidelines and relevant regulatory regulations, and the ability to implement and advise team members on implementation
- Develop and maintain best practice guidelines, study tool templates and Standard Operating Procedures (SOP)s for the clinical affairs/biometrics team
- Ensure the study-specific DM documents in the Trial Master File (TMF) are of high quality and are filed on time to support inspection and submission activities.
- Other projects may be assigned rom time to time.
Who You’ll Be
Because our patient always come first, we seek the highest caliber candidates with the following background and experience:
- BS degree in life science, statistics, computer science or equivalent relevant degree with 5+ years relevant work experience in biotechnology, CRO, or pharmaceutical industry.
- Strong Experience with EDC (iMEDnet, REDCAP, etc) study build and administration experience and CTMS
- Strong programming experience in SAS and Business Objects preferred
- Demonstrated knowledge of data management processes and principles in area of responsibility
- Working knowledge of clinical research, industry standards (CDISC), FDA & ICH, GCP, GCDMP, and related regulatory requirements
- Familiarity with MedDRA/WHO-Drug coding dictionaries
- Solid business ethics
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
- Proficiency in the use of SQL databases
- Strong verbal and written communication skills including ability to communicate remotely
- Strong interpersonal and presentation skills
- Good project management skills with attention to detail and quality
- Strong skills in building a collaborative environment and in coaching and mentoring colleagues
- Good sense of humor-we take our patient and science seriously but not ourselves.
What To Expect at 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
Compensation and Benefits
We’re committed to a comprehensive total employee compensation Program that reflects progressive philosophies that recognize the importance of everyone. Our Program includes an award winning and extensive benefits program is designed to meet your personal and family health, as well as financial security needs.
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.
- Physical requirements include sitting, walking, standing for prolonged periods, possible radiation exposure.
- Willingness to:
- Participate in all relevant formal training events.
- Observe and comply with all Sirtex corporate policies.
- Work within, and ensure adherence to quality system procedures, work instructions, and other quality systems.
- Work within, and ensure adherence to health, safety, and environmental management system procedures, instructions, and other necessary factors.
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, I 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.