Clinical Data Manager

A new opportunity to join a leading phase I specialist life-science business. You will be working with cutting-edge technology and methodologies - providing an opportunity to work with the latest industry technology and advancements in the field.

As a growing business, tailored progression opportunities are offered to suit individual needs with direct support from senior management to ensure healthy growth in the team.

You will be joining a collaborative smaller team environment and given the full scope of responsibility of managing all data management activities, supporting the project leads, in a hands-on and client facing role.

This role will be based in their Melbourne office in a hybrid capacity.

Suitable for an experienced Clinical Data Manager with experience in a CRO or similar setting.

Key Responsibilities:

The Clinical Data Manager will be responsible for managing all aspects of clinical trial data from study start-up through database lock. This includes developing and implementing data management plans, designing case report forms, overseeing data entry and validation, and generating study-specific data reports. The ideal candidate will be a detail-oriented, self-starter who can work independently and collaboratively in a fast-paced, small company environment.

• Develop and implement data management plans for clinical trials
• Design case report forms (CRFs) and review/edit CRFs created by CROs or study teams
• Manage electronic data capture (EDC) systems and oversee data entry and validation
• Ensure data quality and accuracy by conducting data review and query resolution
• Create and review data reports for clinical study team and regulatory submissions
• Perform database lock and archiving activities in accordance with SOPs and regulatory requirements
• Contribute to the development and improvement of data management processes and procedures
• Collaborate with cross-functional study teams to ensure timely and accurate data collection and reporting

Qualifications:

• Bachelor's degree in a relevant scientific discipline (e.g., biology, chemistry, statistics) or equivalent experience
• Minimum of 2 years of experience in clinical data management, preferably in a CRO environment
• Knowledge of ICH/GCP guidelines and FDA/EMA regulations
• Experience with EDC systems and CRF design

Title: Clinical Data Manager

Location: Melbourne (hybrid offered)

Salary: Circa $100,000 plus superannuation (dependent on experience)

Do not hesitate to apply if you are interested. Please send your CV to Keeley Munday at kmunday@i-pharmconsulting.com 02 8310 5854 or apply direct to this link for a further confidential discussion.

Associated Keywords: CRA, Clinical, Pharmaceutical, Pharma, CRO, Clinical Research Organisation, Clinical Data Manager, Australia, Melbourne, Victoria, , Oncology, Respiratory, Cardiovascular, Monitoring, Sites, SIV, Database Lock, Project Manager, Data Lead, Hybrid, Remote, Office, Immunotherapy, Cart-T.