SUMMARY
An exciting opportunity has arisen for a Clinical Operations Manager to join an exciting start-up environment in a Clinical-Stage Biotech!
The Clinical Operations Manager leads and manages clinical study operations in the execution of clinical trials in Australia to ensure compliance with regulatory authorities, GCP, ICH, & company SOPs.
RESPONSIBILITIES
• Manage the day-to-day clinical operations, including management of Australia-based CRAs
• Assist with the process of clinical protocol preparation, submission and HREC review to include tracking and coordination to ensure compliance with relevant federal and local regulations and policies.
• Provide key input into planning of clinical studies to meet company objectives.
• Assist with executing on the company’s clinical study pipeline ensuring appropriate resources are identified and available.
• Assist with the generation of study documents including protocols, investigator brochures, case report forms, recruiting materials, and informed consent documents.
• Assist with the generation of clinical study reports.
• Coordinate with the clinical data management team, if applicable, to provide support and assistance database specifications, data entry and verification, and data queries and reports.
• Identify site needs, provide solutions to facilitate the clinical trial process.
• Act as primary point of contact for study sites.
• Assist in initial and ongoing site personnel training, as required.
• Provide solutions and collaborate with Clinical Operations and study team personnel towards securing Investigator compliance and developing efficiency systems.
• Oversee material logistics for assigned study sites.
• Monitoring Activities:
• Participant and assist, when needed, in field monitoring in accordance with GCP and company SOPs.
• Conduct site monitoring visits (on-site and remote) in accordance with Clinical Monitoring Plan to ensure compliance with the Protocol, Monitoring plan, applicable regulatory, HREC, and company standards, guidelines and policies.
• Ensure compliance to appropriate guidelines as it relates to Good Clinical Practices as well as federal and local laws.
• Communicate visit findings with Clinical team, and site personnel, when appropriate, and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up.
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan.
• Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, GCP and SOPs.
QUALIFICATIONS
• 7+ years related experience in the area of clinical research trial monitoring
• BS degree or equivalent experience
• Knowledge of federal and local regulations and policies pertinent to research involving human subjects
• Knowledge of Good Clinical Practice, ICH and Declaration of Helsinki.
• Working knowledge of Australia TGA regulatory policies, procedures and requirements.
• Excellent communication, interpersonal and organizational skills
• Ability to collaborate in a team environment as well as work independently
• Self-starter with the ability to manage multiple projects in a dynamic environment
DURATION
Full-time, permanent
SALARY
Attractive salary plus bonus & stocks
LOCATION
Australia (fully remote)
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
TO APPLY
Please click ‘apply’ or contact Sam Chapple (Recruitment Manager, APAC) at Planet Pharma for more information:
T: : +61 (0) 37 068 9299
Linkedin: https://www.linkedin.com/in/sam-chapple-42b459131/
Location: , , AU
Offer Expires: 2024-11-21 22:31:46
Job Posting Language: en
LinkedIn: Apply Here
Hacendo.com: Apply Here
Kit Job: Apply Here