AddressIt's time to grow our team again! If you love data, are super organized, and are a good communicator then we may be a good fit for you. We are a passionate team of data professionals who thrive on high-quality project delivery for our clients. We are on the lookout for 2 talented new DMs to join our crew!
About the business
PureCDM is committed to delivering high-quality Clinical Data to support the development of new medicines and devices. We specialise in customising technology and putting Clinical Data front and centre to meet the evolving needs and complexities of Biotech and MedTech clinical trials.
We place a strong emphasis on collaboration with both project teams and clients to proactively identify potential data risks and challenges. We prioritize building strong relationships with all stakeholders, exceeding client expectations, and earning their trust through our dedication to doing what's right.
With an uncompromising commitment to quality, our team is exceptionally trained and mentored, rigorously supported, and empowered to move fast and stay flexible whilst wholeheartedly staying focused on data quality.
About the role
We are seeking an experienced Lead Clinical Data Manager to manage end-to-end data management activities for our organization. The successful candidate will be responsible for ensuring the accuracy, completeness, and consistency of clinical trial data, as well as overseeing the development and implementation of data management plans. The Clinical Data Manager will collaborate with cross-functional teams to ensure that clinical trials are conducted in compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
The role is exciting and dynamic, with tasks varying from project to project. Therapeutic experience in neurology and oncology will be highly regarded along with a curiosity to learn and investigate new scientific discoveries.
Key responsibilities:
- Develop and implement data management plans in collaboration with cross-functional teams
- Manage the collection, processing, and validation of clinical trial data to ensure accuracy, completeness, and consistency
- Review and resolve data discrepancies in collaboration with study teams
- Ensure compliance with regulatory requirements and GCP guidelines
- Collaborate with cross-functional teams to identify and resolve data-related issues
- Oversee the development and maintenance of data management documentation, including data management plans, case report forms, and data transfer agreements
- Participate in the development and review of study protocols, statistical analysis plans, and clinical study reports
- Provide input on database design and development, and collaborate with data management vendors as necessary
- Manage timelines and deliverables related to data management activities
- Ensure adherence to data management best practices and standard operating procedures
- Provide input on process improvement initiatives related to data management
Skills and experience
- Min Bachelor’s degree in biological/life sciences
- Min 5 years of experience as a Clinical Data Manager in a CRO setting, including 2 year of experience leading data management teams
- Able to work flexible hours if required to meet deadlines and/or facilitate communications on global studies
- Strong understanding of regulatory requirements and GCP guidelines
- Experience with EDC systems and other data management tools
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams
- Strong organizational and project management skills, with the ability to manage multiple priorities and timelines
We offer a competitive salary, comprehensive benefits, and opportunities for career growth and development. If you are an experienced Lead Clinical Data manager looking for a challenging and rewarding leadership role, please apply today.
Positions are full-time and based in Melbourne or Adelaide
Please submit your CV and cover letter outlining why you are interested in the position. Applications without a cover letter will not be considered.
