Clinical Trial Manager
- $110,000 - $150,000
- La Jolla, CA
***Clinical Trial Manager Needed***
A bit about us:
Growing Biotech company in the San Diego area!!
Why join us?
Great Benefits
Great Culture
Great Compensation
Great Culture
Great Compensation
Job Details
Job Details:
We are seeking a highly motivated and experienced Permanent Clinical Trial Manager to join our dynamic team in the Scientific industry. The successful candidate will play a pivotal role in the planning, implementation, and management of clinical trials from start to finish. This includes protocol development, regulatory affairs, data management, medical writing, and CMC development. The Clinical Trial Manager will work cross-functionally with internal departments and external resources to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, FDA regulations, and ICH/GCP guidelines.
Responsibilities:
1. Oversee the planning and execution of clinical trials, ensuring they are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
2. Lead the development of clinical trial protocols, informed consent forms, and other clinical documents.
3. Manage the submission of protocols, amendments, and other documents to regulatory agencies.
4. Oversee data management activities, including CRF design, database development, data validation, and data analysis.
5. Coordinate with medical writing personnel to prepare clinical study reports, publications, and presentations.
6. Oversee CMC development activities, ensuring that clinical trial materials are available when needed.
7. Ensure that all adverse events, protocol deviations, and other clinical issues are appropriately documented and followed up.
8. Monitor and report on the progress of clinical trials, providing regular updates to senior management.
9. Develop and maintain strong relationships with investigators, vendors, and other key stakeholders.
10. Participate in the selection, training, and oversight of clinical research associates and other clinical staff.
Qualifications:
1. Bachelor’s degree in a scientific discipline; advanced degree preferred.
2. Minimum of 3 years of experience in clinical trial management, with a strong understanding of the drug development process.
3. Proven experience in the development of clinical trial protocols, informed consent forms, and other clinical documents.
4. Demonstrated knowledge of regulatory affairs, including the submission of documents to regulatory agencies.
5. Strong experience in data management, including CRF design, database development, data validation, and data analysis.
6. Experience in medical writing, including the preparation of clinical study reports, publications, and presentations.
7. Familiarity with CMC development and the management of clinical trial materials.
8. Excellent organizational skills, with an ability to manage multiple tasks and projects simultaneously.
9. Strong communication skills, with an ability to effectively convey complex information to a variety of audiences.
10. Proficiency in Microsoft Office Suite and clinical trial management systems.
11. Willingness to travel as needed to oversee clinical trial sites.
We are seeking a highly motivated and experienced Permanent Clinical Trial Manager to join our dynamic team in the Scientific industry. The successful candidate will play a pivotal role in the planning, implementation, and management of clinical trials from start to finish. This includes protocol development, regulatory affairs, data management, medical writing, and CMC development. The Clinical Trial Manager will work cross-functionally with internal departments and external resources to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, FDA regulations, and ICH/GCP guidelines.
Responsibilities:
1. Oversee the planning and execution of clinical trials, ensuring they are completed on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
2. Lead the development of clinical trial protocols, informed consent forms, and other clinical documents.
3. Manage the submission of protocols, amendments, and other documents to regulatory agencies.
4. Oversee data management activities, including CRF design, database development, data validation, and data analysis.
5. Coordinate with medical writing personnel to prepare clinical study reports, publications, and presentations.
6. Oversee CMC development activities, ensuring that clinical trial materials are available when needed.
7. Ensure that all adverse events, protocol deviations, and other clinical issues are appropriately documented and followed up.
8. Monitor and report on the progress of clinical trials, providing regular updates to senior management.
9. Develop and maintain strong relationships with investigators, vendors, and other key stakeholders.
10. Participate in the selection, training, and oversight of clinical research associates and other clinical staff.
Qualifications:
1. Bachelor’s degree in a scientific discipline; advanced degree preferred.
2. Minimum of 3 years of experience in clinical trial management, with a strong understanding of the drug development process.
3. Proven experience in the development of clinical trial protocols, informed consent forms, and other clinical documents.
4. Demonstrated knowledge of regulatory affairs, including the submission of documents to regulatory agencies.
5. Strong experience in data management, including CRF design, database development, data validation, and data analysis.
6. Experience in medical writing, including the preparation of clinical study reports, publications, and presentations.
7. Familiarity with CMC development and the management of clinical trial materials.
8. Excellent organizational skills, with an ability to manage multiple tasks and projects simultaneously.
9. Strong communication skills, with an ability to effectively convey complex information to a variety of audiences.
10. Proficiency in Microsoft Office Suite and clinical trial management systems.
11. Willingness to travel as needed to oversee clinical trial sites.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.