Clinical Trials Data Specialist

3 days ago

Camperdown, Australia Chris O’Brien Lifehouse Full time

**The Role**

Reporting to the Business Manager, the purpose of the Clinical Trial Data Specialist position is to complete data entry requirements of participants participating in clinical trials. Collect and record relevant trial data and work with the Principal Investigator and Sponsors to ensure accurate and timely data entry.

**Key Responsibilities**
- Enter data from Chris O’Brien Lifehouse electronic medical records into sponsors electronic data management systems in line with the relevant clinical trial protocol to meet deadlines in line with the contract requirements, in accordance with ICH GCP.
- Resolve data queries as they arise in line with protocol & contract requirements. Work with the clinical trials team to Sponsors, including resolution of concerns to her mutual satisfaction of all parties, in line with ICH GCP.
- Ensure regular communication & escalation to expedite issue resolution of outstanding queries & resolution to support Data Base Locks for Sponsors with the Operations Manager & or Business Manager of Clinical trials.

**Selection Criteria**
- Bachelor’s degree in a scientific or healthcare-related field
- Understanding of clinical trial processes, data management principles and regulatory guidelines
- Proficiency in electronic data capture (EDC) systems and clinical data management software
- experience in clinical data management or a similar role in the pharmaceutical or clinical research industry
- Ability to work both as a team member and autonomously
- Demonstrated high level of interpersonal skills, including verbal and written communication
- Excellent planning and organisational skills
- Evidence of immunisations to comply with the NSW Health Occupational Assessment, Screening & Vaccination against Specified Infectious Diseases Policy for a Category B position

**Benefits**
- Optional NFP salary packaging - increase your take home pay with $15,900 tax free benefit + meal and entertainment card.
- Fitness Passport Access.
- Employee Assistance program.
- Onsite gym.
- Access to e-learning programs and an opportunity to progress your career.

**Culture**
- At Chris O’Brien Lifehouse, we are committed to providing a working environment where each individual is valued, respected, and supported to progress. Our priority is to ensure culture, policies, and processes are truly inclusive and that no one is disadvantaged on the basis of their Aboriginal and Torres Strait Islander identity, gender, culture, disability, LGBTIQA+ identities, family and caring responsibilities, age, or religion. We encourage everyone who meets the selection criteria and shares Chris O'Brien Lifehouse values to apply._

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