Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Summary We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site ...
Specialist Study Management
Wilmington, DE · On-site
Contribute to electronic applications/submissions by handling clinical-regulatory documents ... High ability to manage priorities and Local Study Team expectations * Independent yet able to work ...
Quick apply
Specialist Study Management
Wilmington, DE · On-site
Contribute to electronic applications/submissions by handling clinical-regulatory documents ... High ability to manage priorities and Local Study Team expectations * Independent yet able to work ...
Collaborate with clinical operations, data management, sponsors, CROs, and study teams to ensure efficient clinical trial execution, data quality, and regulatory compliance throughout the study ...
Collaborate with clinical operations, data management, sponsors, CROs, and study teams to ensure efficient clinical trial execution, data quality, and regulatory compliance throughout the study ...
The Sr. CRA works in close collaboration with (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Country Operations ...
The Sr. CRA works in close collaboration with (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Country Operations ...
Specialist Study Management
$33.75 - $45.25/hr
Bachelor's degree is preferred * 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and ... Maintain and close the local TMF (in electronic or paper form depending on study) ensuring ...
Specialist Study Management
$33.75 - $45.25/hr
Bachelor's degree is preferred * 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and ... Maintain and close the local TMF (in electronic or paper form depending on study) ensuring ...
Manage study timelines, deliverables, risks, and issue resolution * Oversee external vendors, CROs, central laboratories, imaging vendors, and specialty providers * Coordinate Clinical Trial Team ...
Manage study timelines, deliverables, risks, and issue resolution * Oversee external vendors, CROs, central laboratories, imaging vendors, and specialty providers * Coordinate Clinical Trial Team ...
Senior Clinical Research Associate Job Summary The Sr. CRA is responsible for the execution of key ... Identify areas and methods to improve study processes and systems Site Management / Monitoring
Senior Clinical Research Associate Job Summary The Sr. CRA is responsible for the execution of key ... Identify areas and methods to improve study processes and systems Site Management / Monitoring
Clinical Project Manager II - Early Phase Virology /Healthy Volunteer Studies (Sponsor Dedicated -
Wilmington, DE · On-site
Clinical Project Manager II - Early Phase Virology /Healthy Volunteer Studies (Sponsor Dedicated ... You will oversee timelines, budgets, operational risks, study start-up activities, vendor ...
Clinical Project Manager II - Early Phase Virology /Healthy Volunteer Studies (Sponsor Dedicated -
Wilmington, DE · On-site
Clinical Project Manager II - Early Phase Virology /Healthy Volunteer Studies (Sponsor Dedicated ... You will oversee timelines, budgets, operational risks, study start-up activities, vendor ...
Reviews the study scope of work, budget and protocol content and ensures the clinical project team ... Data Management Plan, Communication Plan) as they relate to the clinical trial management ...
Reviews the study scope of work, budget and protocol content and ensures the clinical project team ... Data Management Plan, Communication Plan) as they relate to the clinical trial management ...
Field Clinical Advisor - Cell Therapy - Chicago (IL/WI/IN/MN)
Wilmington, DE · On-site
$197K - $295K/yr
... safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline ...
Field Clinical Advisor - Cell Therapy - Chicago (IL/WI/IN/MN)
Wilmington, DE · On-site
$197K - $295K/yr
... safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline ...
Field Clinical Advisor - Cell Therapy - Chicago (IL/WI/IN/MN)
Wilmington, DE · On-site
$197K - $295K/yr
... safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline ...
Field Clinical Advisor - Cell Therapy - Chicago (IL/WI/IN/MN)
Wilmington, DE · On-site
$197K - $295K/yr
... safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline ...
Cell Therapy- Field Clinical Advisor Midwest (AR, MO, KS, NE, IA, KY)
Wilmington, DE · On-site
$197K - $295K/yr
... safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline ...
Cell Therapy- Field Clinical Advisor Midwest (AR, MO, KS, NE, IA, KY)
Wilmington, DE · On-site
$197K - $295K/yr
... safety management. Additionally, they allow early insight generation. FCAs focus on clinical study protocol expertise and education, optimizing the patient journey, and cell therapy pipeline ...
Lead components of clinical studies and contribute to program-level strategy * Draft and ... Management reserves the right to change or modify such duties as required. Incyte Corporation is ...
Lead components of clinical studies and contribute to program-level strategy * Draft and ... Management reserves the right to change or modify such duties as required. Incyte Corporation is ...
Executive Director, Clinical Development - Hematology Oncology
Wilmington, DE · On-site
$77K - $105K/yr
... clinical study reports (CSRs), investigator materials, regulatory documents, publications, and ... Identifies, evaluates, and proactively manages clinical and program risks, implementing mitigation ...
Executive Director, Clinical Development - Hematology Oncology
Wilmington, DE · On-site
$77K - $105K/yr
... clinical study reports (CSRs), investigator materials, regulatory documents, publications, and ... Identifies, evaluates, and proactively manages clinical and program risks, implementing mitigation ...
Executive Director, Clinical Development - Hematology Oncology
Wilmington, DE · On-site
$77K - $105K/yr
... clinical study reports (CSRs), investigator materials, regulatory documents, publications, and ... Identifies, evaluates, and proactively manages clinical and program risks, implementing mitigation ...
New
Executive Director, Clinical Development - Hematology Oncology
Wilmington, DE · On-site
$77K - $105K/yr
... clinical study reports (CSRs), investigator materials, regulatory documents, publications, and ... Identifies, evaluates, and proactively manages clinical and program risks, implementing mitigation ...
New
Contracts Manager
Wilmington, DE · On-site
$86K - $115K/yr
A managing position providing leadership during the contract management and negotiation process to ... Experience and knowledge of the clinical study and drug development processes and relevant ...
Contracts Manager
Wilmington, DE · On-site
$86K - $115K/yr
A managing position providing leadership during the contract management and negotiation process to ... Experience and knowledge of the clinical study and drug development processes and relevant ...
Senior Medical Director, IAI
Wilmington, DE · On-site
Support data analysis and assembly, including clinical study report writing, contribution to the ... Management reserves the right to change or modify such duties as required. Incyte Corporation is ...
Senior Medical Director, IAI
Wilmington, DE · On-site
Support data analysis and assembly, including clinical study report writing, contribution to the ... Management reserves the right to change or modify such duties as required. Incyte Corporation is ...
Senior/ Executive Medical Director, Medical Lead IAI, Early Clinical Development
Wilmington, DE · On-site
... studies) Duties and Responsibilities * Leads development efforts for assets post-candidate ... Management reserves the right to change or modify such duties as required. We Respect Your Privacy ...
Senior/ Executive Medical Director, Medical Lead IAI, Early Clinical Development
Wilmington, DE · On-site
... studies) Duties and Responsibilities * Leads development efforts for assets post-candidate ... Management reserves the right to change or modify such duties as required. We Respect Your Privacy ...
Clinical Study Manager information
See Delaware salary details
$28.87 - $35
4% of jobs
$35 - $41.12
6% of jobs
$41.12 - $47.24
7% of jobs
$51.84 is the 25th percentile. Wages below this are outliers.
$47.24 - $53.37
9% of jobs
$53.37 - $59.49
15% of jobs
The median wage is $62.19 / hr.
$59.49 - $65.62
18% of jobs
$69.98 is the 75th percentile. Wages above this are outliers.
$65.62 - $71.74
21% of jobs
$71.74 - $77.86
7% of jobs
$77.86 - $83.99
6% of jobs
$83.99 - $90.11
3% of jobs
$90.11 - $96.24
2% of jobs
$28
$62
$96
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Job description
We are looking for a Study Start-Up Manager with extensive experience to lead clinical study start-up activities. This role requires a strong background in regulatory processes, site management, and expertise in ensuring compliance with local and international guidelines, particularly ICH-GCP.
- Lead and manage start-up activities for clinical studies, ensuring compliance with local and international guidelines (ICH-GCP).
- Prepare, review, and track site regulatory documentation throughout the study start-up phase.
- Collaborate with Clinical Research Associates (CRAs) and the local study team to meet start-up milestones.
- Participate in Local Study Team meetings and report on site performance metrics.
- Ensure the timely submission of documents to regulatory authorities and maintain the trial master file (eTMF).
Qualifications
- Minimum 3 years of experience in Clinical Study Start-Up (full-time).
- At least 1 year of hands-on experience with Veeva Vault.
- Strong background in informed consent review and negotiation.
- Bachelor’s degree (higher degree preferred) with knowledge of clinical trial processes (Phases II-IV) and ICH-GCP.
- Excellent communication, organizational, and project management skills.
- Strong problem-solving and negotiation abilities.
About Cedent
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CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.
Industry
It services
Company size
11 - 50 Employees
Headquarters location
Plano, TX, US
Year founded
2008