
Senior Study Start Up Lead
Are you a motivated and experienced professional looking for a challenging role in the pharmaceutical industry? Join Novartis as a Senior Study Start Up Lead and play a critical role in driving the success of our clinical trials. We are seeking a self-starter with exceptional organizational skills and a strong attention to detail to lead our study start-up activities. As a key member of our team, you will have the opportunity to collaborate with cross-functional teams and make a positive impact on the development of life-changing medicines. If you have a Bachelor's degree in a scientific or healthcare field, at least 5 years of experience in clinical research, and a passion for improving patient outcomes, we want to hear from you. Take the next step in your career and join us in our mission to reimagine medicine.
- Lead study start-up activities: Take charge of all aspects of study start-up, including planning, coordinating, and executing activities to ensure timely and successful initiation of clinical trials.
- Collaborate with cross-functional teams: Work closely with various departments, including clinical operations, regulatory affairs, and project management, to ensure smooth and efficient study start-up.
- Ensure compliance: Ensure all study start-up activities are conducted in compliance with company policies, SOPs, and regulatory requirements.
- Develop study start-up plans: Develop and maintain study start-up plans, timelines, and budgets to ensure the timely initiation of clinical trials.
- Manage vendors: Oversee and manage external vendors and contractors involved in study start-up activities to ensure high-quality deliverables.
- Maintain study documentation: Ensure all study start-up documentation is accurate, complete, and filed appropriately according to company and regulatory standards.
- Identify and mitigate risks: Proactively identify potential issues and risks related to study start-up and develop mitigation plans to address them.
- Monitor progress: Continuously monitor and track progress of study start-up activities to ensure they are completed on time and within budget.
- Train and mentor team members: Provide guidance and support to junior team members in study start-up activities and share best practices.
- Stay updated on industry trends: Keep abreast of industry developments and trends related to study start-up and incorporate them into the company's processes and procedures.
- Foster a culture of collaboration: Promote a collaborative and inclusive work environment to encourage cross-functional teamwork and achieve common goals.
- Contribute to process improvement: Continuously evaluate and improve study start-up processes to increase efficiency and effectiveness.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Internal And External Stakeholders At All Levels.
Bachelor's Or Master's Degree In A Relevant Field, Such As Life Sciences, Business Administration, Or Public Health.
Minimum Of 5 Years Of Experience In Clinical Research, With A Focus On Study Start Up Activities.
Strong Knowledge Of Regulatory Requirements And Guidelines For Clinical Trials, Including Ich-Gcp And Local Regulations.
Experience In Managing And Leading Cross-Functional Teams, Including Study Start Up Specialists, Project Managers, And Clinical Research Associates.
Process Improvement
Project Management
Clinical Research
Contract Negotiation
Budget management
Team Leadership
Risk assessment
Regulatory compliance
Data
Protocol Development
Site Selection
Investigator Communication
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Study Start Up Lead in East Hanover, NJ, USA is between $120,000 and $150,000 per year. However, this can vary based on factors such as the specific company, level of experience, and education.
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Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers surgical, ophthalmic pharmaceuticals, and vision care products. The Sandoz segment provides generic pharmaceuticals. The Vaccines & Diagnostics segment provides human vaccines and blood testing diagnostics.

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