- Exciting opportunity to make this role your own
- Rapidly growing global full service CRO with headquarters in Sydney
- Dynamic, collaborative and friendly team
Greenlight Clinical is seeking to appoint a Data Management Head to lead their data management team. The Head of Clinical Data Management will be accountable for ensuring successful delivery of high quality Data Management activities for all phases of clinical trials meeting external client and regulatory requirements to agreed timelines and within budget/scope constraints. In this role you will be tasked with developing SOP’s to support the business, and ensuring compliance with these SOP’s to produce quality and timely deliverables. This role will proactively participate in departmental and cross-functional technology development and process improvement initiatives. This is a key role within the organisation serving as the internal expert in all areas of CDM processes and technology.
- Providing data management support for Australian and global clinical studies from study set-up through to closeout.
- Supporting the implementation, validation, maintenance and upgrading of clinical data systems including electronic data capture (EDC). Working with IT and external vendors, as required.
- Following CDISC conventions, oversee or perform EDC build activities including database design specifications; eCRF design and annotation, generation of data edit checks and data validations and data transfer specifications.
- Co-ordinate and participate in user acceptance testing (UAT) of clinical databases, including edit check testing.
- Management of the preparation and delivery of key clinical data management documents such as Data Management Plans (DMP), Data Validation Plans (DVP), Data Quality Plans (DQP), Edit Check Development and Validation documents, SAE/AE Reconciliation Plans and Data Transfer Specifications.
- Assist in reconciling AE/SAE data in safety database and /or other DM database, including, but not limited to, performing MedDRA and/or WHO Drug coding.
- Providing/overseeing EDC study trial training and creation of user guides.
- Function as DM liaison with cross-functional team members, external vendors and clients.
- Work with senior management to set global data strategy. Lead and/or participate in development and implementation of departmental initiatives, generating continuous quality improvement projects. Develop or improve data management SOPs and guidelines.
- Ensuring all aspects of data management comply with Good Clinical Data Management Practices (GCDMP).
- Supervision and mentoring of junior data management staff.
- Working with BD and clinical colleagues to prepare bid proposals, as required.
Experiences and Qualifications
- Bachelor’s degree in computer science, life science, mathematics or related field or equivalent and relevant formal academic/vocational qualification.
- 8+ years data management experience in the pharmaceutical/biotechnology industry and exposure to global clinical data systems and processes.
- Working knowledge with numerous EDC (Electronic Data Capture) systems for study development.
- Experience in gathering requirements and preparation of specifications for database systems and integrations e.g. ePRO, laboratory data uploads, supply management, IVRS, IWRS, etc. would be highly regarded.
- Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines – e.g. clinical operations and biostatistics.
- Knowledge of regulatory and industry standards (e.g. ICH/FDA guidelines, GCP, CDISC standards, GCDMP, 21 CFR 11, MedDRA and WHO Drug dictionaries etc.) and their application to Data Management practice.
- Demonstrated ability to understand and manage client expectations.
- Superior written and verbal communication skills.
- Previous experience leading Data Management Function would be highly regarded.
GreenLight Clinical Research is a privately owned clinical research company based in Sydney, Australia, which addresses the clinical trial needs of both local and international pharmaceutical, biotechnology and medical device companies.
Our mission is to speed up the global development of safe and effective drugs while guaranteeing high standards of quality and ethics in clinical research. GLC’s broad spectrum of services range from trial design through to regulatory submissions and post-marketing services.
If you are an energetic and driven clinical data management professional ready to lead and contribute to the success of the clinical data management function for this fast paced global organisation then this career opportunity is for you.
This ad is now closed and is an example of a job including maths skills.