Clinical operations manager • jacksonville fl
Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.Develop and manage data management timelines for multiple projects, en... Show more
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The Operations Manager provides coordination and administrative guidance in the administration of departmental functions and programs as required.Employees in this position participate in the desig... Show more
At Johnson & Johnson,we believe health is everything.Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are ... Show more
If you would like the chance to make your mark with the world's largest equipment rental provider, come build your future with United Rentals!.As Operations Manager at United Rentals, you will leve... Show more
The Operations Manager is responsible for leading day-to-day manufacturing operations within a ballistic and hard armor production facility.This role is accountable for effective Operating Model de... Show more
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Operations Manager - To assist the Branch Manager in planning and executing day to day branch operations ranging from scheduling of employees to procuring/maintaining rental equipment for transfer ... Show more
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Associate Director, Clinical Operations.Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatme... Show more
Auto Driveaway, one of the largest professional driveaway companies in the US, is seeking an energetic, safety-focused Operations Manager to run daily operations at our Jacksonville, FL location.Yo... Show more
At Life Couriers, we deeply understand and care about life's critical moments to save lives.We are here to deliver the world's most time-critical diagnostics and therapies.Wherever logistics can m... Show more
The Best Teams are Created and Maintained Here.The Operations Manager is responsible for overseeing the day-to-day branch operations, ensuring efficiency and safety.This role manages staff, resourc... Show more
The average salary range is between $ 120,780 and $ 344,906 year , with the average salary hovering around $ 122,564 year .
The average salary range is between $ 97,022 and $ 164,142 year , with the average salary hovering around $ 126,050 year .
Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting.
Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans.
Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar).
Develop and oversee maintenance all data management documentation for all clinical studies.
Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks.
Oversee data validation processes, including data cleaning, discrepancy management, and query resolution.
Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA).
Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations.
Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes.
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution.
Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution.
Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency.
Develop, implement, and continuously improve clinical data management processes and systems.
Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies.
Bachelor's or master's degree in life sciences, health informatics, computer science, or related field. Advanced degree preferred.
Minimum of 5+ years of experience in clinical data management.
Proven experience managing data across multiple phases of clinical trials.
Proficiency with EDC systems (e.g., Medidata Rave, Medrio).
Strong understanding of CDISC standards (CDASH, SDTM, ADaM) as well as WHO Drug and MedDRA coding.
Familiarity with data reporting tools is a plus.
Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and GCP standards.
Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
Excellent communication, problem-solving, and decision-making skills.
Ability to work collaboratively with cross-functional teams and manage relationships with external vendors.
Certified Clinical Data Manager (CCDM) or similar certification is preferred.
