
Clinical Study Planning Manager
Welcome to Amgen, a leading biotechnology company dedicated to developing innovative medicines for patients with serious illnesses. We are seeking a highly motivated and experienced Clinical Study Planning Manager to join our team. In this role, you will have the opportunity to lead and oversee the planning and execution of clinical studies to support the development of life-changing therapies. We are looking for someone with a strong background in clinical research, exceptional project management skills, and a passion for driving success in a fast-paced and constantly evolving industry. If you are a driven and collaborative individual with a desire to make a difference in the lives of patients, we encourage you to apply for this exciting opportunity.
- Lead and oversee the planning and execution of clinical studies to support the development of new medicines for patients with serious illnesses.
- Manage the entire clinical study planning process, including protocol development, study design, site selection, and budget management.
- Collaborate with cross-functional teams to develop and implement study timelines and ensure adherence to project milestones.
- Develop and maintain strong relationships with key stakeholders, including internal teams, external vendors, and clinical trial sites.
- Ensure compliance with all regulatory requirements, internal policies, and industry standards.
- Drive continuous improvement in study planning processes and procedures to increase efficiency and effectiveness.
- Monitor study progress and identify and address any potential issues or risks that may impact timelines or quality of data.
- Develop and manage study budgets, including forecasting and tracking expenses.
- Provide regular updates and reports on study progress to senior management and other relevant stakeholders.
- Mentor and support team members to ensure their professional growth and development.
- Stay informed of industry trends and best practices in clinical study planning and incorporate them into study planning processes.
- Collaborate closely with other departments, such as clinical operations, data management, and regulatory affairs, to ensure seamless study execution.
- Communicate and collaborate effectively with study sites to ensure smooth study start-up and ongoing trial management.
- Represent the company at conferences and meetings related to clinical study planning and share best practices and learnings with the team.
- Uphold Amgen's values of integrity, quality, and teamwork in all aspects of work.
Bachelor's Degree In A Relevant Field Such As Life Sciences, Public Health, Or Clinical Research.
Minimum Of 5 Years Of Experience In Clinical Study Planning And Management In The Pharmaceutical Or Biotechnology Industry.
Comprehensive Knowledge Of Global Clinical Trial Regulations, Good Clinical Practice (Gcp) Guidelines, And International Conference On Harmonization (Ich) Guidelines.
Strong Project Management Skills With The Ability To Effectively Plan, Coordinate, And Execute Multiple Studies Simultaneously.
Excellent Communication And Leadership Skills With The Ability To Collaborate With Cross-Functional Teams And External Stakeholders To Achieve Study Objectives.
Communication Skills
Project Management
Data Analysis
Time Management
Clinical Research
Budget management
Team Leadership
Risk assessment
Regulatory compliance
Cross-Functional Collaboration
Protocol Development
Problem
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
Decision-making
According to JobzMall, the average salary range for a Clinical Study Planning Manager in Washington, DC, USA is $85,000 to $120,000 per year. This can vary depending on factors such as education, experience, and the specific company or organization the individual is working for.
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Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.

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