
Sr. Clinical Trials Manager, Clinical Operations- Inflammation
Are you a seasoned Clinical Trials Manager with a passion for making a difference in the field of Inflammation? Do you have a strong track record of successfully managing clinical operations for complex trials? If so, Gilead Sciences is looking for you! As a Sr. Clinical Trials Manager in our Inflammation team, you will play a critical role in the development and execution of clinical trials for our innovative therapies. We are seeking a highly motivated and organized individual with a deep understanding of clinical trial management, a strong scientific background, and excellent communication and leadership skills. Join us in our mission to improve the lives of patients with inflammatory diseases.
- Manage the overall planning, implementation, and execution of clinical trials for inflammatory diseases, ensuring adherence to timelines, budget, and quality standards.
- Lead and oversee cross-functional teams to ensure successful conduct of clinical trials, including study start-up, monitoring, and close-out activities.
- Develop and maintain strong relationships with study sites, investigators, and vendors to support efficient and effective trial execution.
- Collaborate with internal and external stakeholders to develop and refine study protocols, study budgets, and study timelines.
- Monitor study progress and identify and address any potential issues or risks that may impact the successful completion of the trial.
- Ensure compliance with all relevant regulations and guidelines, including GCP, ICH, and local regulatory requirements.
- Manage study budgets and timelines, including forecasting and tracking of study expenses.
- Communicate study updates and progress to internal and external stakeholders, including senior management, study team members, and study sites.
- Mentor and train junior team members, providing guidance and support to ensure their professional growth and development.
- Represent the company at scientific and industry conferences, presenting on clinical trial progress and results.
- Contribute to the development and implementation of departmental processes and procedures to continuously improve clinical trial management.
- Stay current on industry trends, regulations, and best practices related to clinical trial management for inflammatory diseases.
- Uphold the company's values and culture, promoting a patient-centric approach to clinical trial conduct and data collection.
- Collaborate with cross-functional teams to ensure the timely and accurate completion of all required study documentation, including protocols, informed consent forms, and study reports.
- Participate in study audits and regulatory inspections, ensuring all required documentation and processes are in place and up to date.
- Act as a subject matter expert for clinical trial management, providing guidance and support to other teams and departments as needed.
- Ensure all study activities are conducted in accordance with ethical and safety standards, priorit
Strong Understanding Of Fda Regulations And Ich/Gcp Guidelines.
Bachelor's Or Master's Degree In A Relevant Field Such As Life Sciences, Nursing, Or Pharmacy.
Minimum Of 5 Years Of Experience In Clinical Operations, Specifically In The Area Of Inflammation.
Proven Track Record Of Successfully Managing Multiple Clinical Trials Simultaneously, From Planning To Closeout.
Excellent Communication And Leadership Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And External Partners.
Quality Assurance
Project Management
Vendor Management
Data Analysis
Budget management
Scientific writing
Team Leadership
Risk assessment
Regulatory compliance
Clinical Trials
Protocol Development
Subject Recruitment
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Sr. Clinical Trials Manager, Clinical Operations- Inflammation in Foster City, CA, USA is $140,000 - $200,000 per year. However, this can vary based on factors such as experience, education, and specific job responsibilities. Additionally, factors such as the company's size and industry can also impact the salary range for this position.
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Gilead Sciences, Inc., is an American biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

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