Clinical Data Manager is responsible to ensure the integrity, accuracy and compliance of clinical trial data with study and regulatory requirements, SOPs and CDISC data standards. CDMS will be responsible for overseeing data quality for Telix clinical trials, ensuring Electronic Data Capture (EDC) development per study requirements, overseeing data cleaning activities and managing external data transfers. They will lead data management activities for assigned Telix clinical trials and manage deliverables per timelines, from study start up through database lock and study close-out. They will ensure optimized data collection, flow and access across EDC and non-EDC sources.
Key Accountabilities:- Will act as primary data management SME for assigned Telix clinical trials.
- Oversee and support all activities for EDC build including Data Management Plan (DMP), Data review plans, EDC build specifications, User Acceptance Testing (UAT), electronic Case Report Forms (eCRF) Completion Guidelines and other activities as needed.
- Oversee data entry and cleaning activities for assigned Telix clinical trials.
- Oversee completeness of data management documentation for eTMF.
- Liaises with external vendors to support timelines, deliverables and data transfers.
- May assist with review of data related deliverables.
- May assist in development and review of protocol and Statistical Analysis Plan (SAP).
- Support audits, inspections, study kick off meetings as needed.
- Ensure compliance with Good Clinical Practice (GCP), CDISC standards and other regulations as applicable.
- Support internal Clinical Data Management initiatives.
Position Requirements:Education and Experience:- Bachelor's degree in Health Information Management, Life Sciences or equivalent work experience. Advanced degree preferred.
- 3+ years of experience in clinical trial data management with a minimum of 1 year experience in leading data management activities independently for complex global clinical trials REQUIRED.
- Demonstrated ability to oversee multiple vendors and managing strict timelines for deliverables for multiple global complex clinical trials.
- Experience with creation of all data management documents including but not limited to eCRF specifications, edit check specifications, Data Management Plans, Data Review Plans, eCRF Completion Guidelines, UAT plans and test scripts and data transfer agreements.
- Accuracy, strong attention to detail, highly developed organizational skills and proven ability to establish priorities, manage tasks, exercise sound judgement and work to multiple, tight and conflicting deadlines.
- Demonstrated ability to work productively both independently and as part of a team, taking initiative and exercising sound judgement in resolving matters that may arise as part of normal daily work.
- Demonstrated knowledge of CDISC, SDMT, CDASH, GCP and other regulatory requirements for global clinical trials.
- Demonstrated knowledge of the collaborative functions and activities of global clinical trials.
- Some travel (20%) may be required with a potential to travel over weekends.
Key Capabilities:- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
