Clinical Data Manager

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company developing precision medicine products for cancer and rare diseases. The Clinical Data Manager ensures the integrity, accuracy, and compliance of clinical trial data while leading data management activities, EDC development, data cleaning, vendor coordination, and deliverables from study start-up through close-out.

Responsibilities

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

Preferred

Advanced degree preferred

Advanced Degree

Benefits

Annual performance-based bonuses

Equity-based incentive program

Generous vacation

Paid wellness days

Support for learning and development

Hybrid and remote work arrangements

Company

Global biopharmaceutical company developing and commercializing radiopharmaceuticals

North Melbourne, Victoria, AUS

http://www.telixpharma.com/

Founded in 2015

1001-5000 employees

Qualifications

Bachelor's degree in Health Information Management, Life Sciences or equivalent work experience

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

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

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.

Required skills

Clinical trial data management, Electronic Data Capture (EDC), CDISC, SDTM, CDASH, Clinical Practice (GCP), Global clinical trials, Data Management Plans, Data Review Plans, eCRF specifications, User Acceptance Testing (UAT), Data transfer agreements

Preferred skills

Advanced degree preferred

Experience

3+ years