Project Manager
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Job Description
Project Manager responsible for managing cross-functional teams and clinical trial delivery at Catalyst Clinical Research, ensuring regulatory compliance and meeting timelines.
Responsibilities:
- Accountable for achieving successful delivery of clinical trial team activities at the trial/program level.
- Leads and directs cross functional teams.
- Proactively identifies, resolves/mitigates, and escalates risks and/or issues.
- Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs.
- Manages study vendors, patient enrollment and liaises with investigators and study sites.
- Communicates to the sponsor with strict attention to budget and timeline estimates.
- Ensures the completion of all project deliverables from contract signature to delivery of final clinical study report.
- Collaborates with internal safety team member to develop Safety Management Plan.
- Monitors quality of vendor deliverables and addresses any issues.
Requirements:
- Minimum of 5 years’ experience with clinical research methodology and product development activities (supporting regulatory filing, study design, monitoring, study coordination, data management, data analysis).
- Prior project management or project lead coordination experience is required.
- Minimum of 5 years’ experience with clinical research methodology and product development activities in Australia, New Zealand and Asia Pacific.
- Prior oncology project management or project lead coordination required.
- Preferred experience in bid defense process.
- Proficient with Microsoft Office Suite.
- Excellent written and oral communication skills.
- Demonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners.
- Strong organizational, problem-solving, and analytical skills.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Exceptional attention to detail.
- Demonstrated track record in leading successful teams to achieve aggressive timelines using creative problem-solving techniques.
- Collaborative leadership style.
Benefits:
- Ability and willingness to travel as needed
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