eTMF Manager at Jobot
Germantown, MD 20875
About the Job
NEW eTMF Manager Opportunity with growing biotech company!
This Jobot Job is hosted by: Audrey Block
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $150,000 - $175,000 per year
A bit about us:
Prep-ipo Biotech company with strong funding, focused in the Oncology space. We are looking for an eTMF Manager to join our team!
Why join us?
401K with a match
Health/Medical/Dental benefits
Competitive compensation and stock options
Opportunity for growth
Work with an exciting biotechnology company
Job Details
Job Details:
Are you a seasoned professional in the biopharma industry with experience as an eTMF Manager? We are on the hunt for a Permanent eTMF Manager who can bring their expertise, precision, and enthusiasm to our dynamic team. This is a rare opportunity to join a leading organization in the biotech industry, where you will be instrumental in driving the management of electronic Trial Master Files (eTMF). The successful candidate will be responsible for overseeing the quality, completeness, and regulatory compliance of the eTMF system and will play a key role in the successful execution of clinical trials.
Responsibilities:
As a eTMF Manager, your primary responsibilities will include:
1. Lead the implementation, maintenance, and archival of eTMF for all clinical trials.
2. Ensuring the quality, completeness, and regulatory compliance of the eTMF system.
3. Developing and implementing eTMF standard operating procedures (SOPs) and guidelines.
4. Training and supporting study teams in the use of the eTMF system.
5. Conducting regular audits of the eTMF system to ensure data integrity and compliance with regulatory standards.
6. Collaborating with cross-functional teams to resolve any issues related to eTMF.
7. Keeping up-to-date with the latest industry trends, regulations, and best practices.
Qualifications:
The ideal candidate will possess the following qualifications:
1. A Bachelor's degree in a scientific or related field. A Master's degree or higher is preferred.
2. A minimum of 5 years of experience in managing eTMF in the biopharma industry.
3. In-depth knowledge of clinical trial processes and regulatory requirements related to eTMF.
4. Proficiency in the use of eTMF systems and other clinical trial management software.
5. Excellent organizational and project management skills.
6. Strong communication and interpersonal skills.
7. Ability to work effectively in a team-oriented environment.
8. Proven ability to handle multiple tasks and meet deadlines.
9. Strong problem-solving skills and attention to detail.
10. Certified Clinical Data Manager (CCDM) or equivalent certification is a plus.
This is an exciting opportunity to bring your expertise to a leading organization in the biotech industry and play a key role in the successful execution of clinical trials. If you are passionate about ensuring the quality and regulatory compliance of eTMF and are looking for a challenging and rewarding career, we would love to hear from you!
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Audrey Block
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $150,000 - $175,000 per year
A bit about us:
Prep-ipo Biotech company with strong funding, focused in the Oncology space. We are looking for an eTMF Manager to join our team!
Why join us?
401K with a match
Health/Medical/Dental benefits
Competitive compensation and stock options
Opportunity for growth
Work with an exciting biotechnology company
Job Details
Job Details:
Are you a seasoned professional in the biopharma industry with experience as an eTMF Manager? We are on the hunt for a Permanent eTMF Manager who can bring their expertise, precision, and enthusiasm to our dynamic team. This is a rare opportunity to join a leading organization in the biotech industry, where you will be instrumental in driving the management of electronic Trial Master Files (eTMF). The successful candidate will be responsible for overseeing the quality, completeness, and regulatory compliance of the eTMF system and will play a key role in the successful execution of clinical trials.
Responsibilities:
As a eTMF Manager, your primary responsibilities will include:
1. Lead the implementation, maintenance, and archival of eTMF for all clinical trials.
2. Ensuring the quality, completeness, and regulatory compliance of the eTMF system.
3. Developing and implementing eTMF standard operating procedures (SOPs) and guidelines.
4. Training and supporting study teams in the use of the eTMF system.
5. Conducting regular audits of the eTMF system to ensure data integrity and compliance with regulatory standards.
6. Collaborating with cross-functional teams to resolve any issues related to eTMF.
7. Keeping up-to-date with the latest industry trends, regulations, and best practices.
Qualifications:
The ideal candidate will possess the following qualifications:
1. A Bachelor's degree in a scientific or related field. A Master's degree or higher is preferred.
2. A minimum of 5 years of experience in managing eTMF in the biopharma industry.
3. In-depth knowledge of clinical trial processes and regulatory requirements related to eTMF.
4. Proficiency in the use of eTMF systems and other clinical trial management software.
5. Excellent organizational and project management skills.
6. Strong communication and interpersonal skills.
7. Ability to work effectively in a team-oriented environment.
8. Proven ability to handle multiple tasks and meet deadlines.
9. Strong problem-solving skills and attention to detail.
10. Certified Clinical Data Manager (CCDM) or equivalent certification is a plus.
This is an exciting opportunity to bring your expertise to a leading organization in the biotech industry and play a key role in the successful execution of clinical trials. If you are passionate about ensuring the quality and regulatory compliance of eTMF and are looking for a challenging and rewarding career, we would love to hear from you!
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
150,000 - 175,000 /year
