Senior Clinical Trial Manager
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Job Description: Senior Study Manager
We are seeking an experienced and highly skilled Senior Study Manager to join our clinical operations team. This position requires a minimum of 12-15 years of experience in clinical operations, with at least 7 years of specialized experience in global study management.
Responsibilities:
- Lead and oversee the operational execution of global clinical trials, ensuring adherence to ICH/GCP guidelines, regulatory requirements, and internal standard operating procedures.
- Collaborate closely with cross-functional teams, including clinical research associates, data management, biostatistics, and other stakeholders, to ensure seamless study conduct and timely delivery of high-quality data.
- Develop and implement comprehensive study plans, risk management strategies, and contingency plans to mitigate potential risks and ensure successful study execution.
- Monitor study progress, identify potential issues, and implement corrective actions as needed, ensuring timely resolution of any deviations or protocol violations.
- Manage vendor selection, contracting, and oversight, ensuring effective collaboration and performance of external partners.
- Participate in the development of study protocols, informed consent forms, and other essential study documents, providing operational input and expertise.
- Contribute to the preparation and review of regulatory submissions, safety reports, and other documentation as required.
- Represent the organization at investigator meetings, sponsor meetings, and other external events, fostering effective communication and collaboration with study stakeholders.
Qualifications:
- A minimum of 12-15 years of experience in clinical operations, with at least 7 years of dedicated global study management experience.
- Preference will be given to candidates with experience from Japanese biotech or pharmaceutical companies.
- Strong understanding of ICH/GCP guidelines, regulatory requirements, and industry best practices in clinical trial management.
- Proven track record of successfully leading and managing complex, global clinical trials across various therapeutic areas.
- Excellent communication, collaboration, and interpersonal skills, with the ability to effectively interact with cross-functional teams, vendors, and external stakeholders.
- Proficiency in project management, risk management, and problem-solving skills.
- Strong organizational skills, attention to detail, and the ability to multitask and prioritize in a fast-paced environment.
- Proficiency in relevant software applications and clinical trial management systems.
- Bachelor's degree in a scientific or related field; advanced degree in a relevant discipline is preferred.
- Willingness and ability to commute to our office in New Jersey, as this is a hybrid role.
We offer a competitive compensation package and an opportunity to be part of a dynamic and innovative team dedicated to advancing healthcare solutions. If you possess the required qualifications and are passionate about contributing to the success of global clinical trials, we encourage you to apply for this exciting opportunity.
Job Description: Senior Study Manager
We are seeking an experienced and highly skilled Senior Study Manager to join our clinical operations team. This position requires a minimum of 12-15 years of experience in clinical operations, with at least 7 years of specialized experience in global study management.
Responsibilities:
Lead and oversee the operational execution of global clinical trials, ensuring adherence to ICH/GCP guidelines, regulatory requirements, and internal standard operating procedures.
Collaborate closely with cross-functional teams, including clinical research associates, data management, biostatistics, and other stakeholders, to ensure seamless study conduct and timely delivery of high-quality data.
Develop and implement comprehensive study plans, risk management strategies, and contingency plans to mitigate potential risks and ensure successful study execution.
Monitor study progress, identify potential issues, and implement corrective actions as needed, ensuring timely resolution of any deviations or protocol violations.
Manage vendor selection, contracting, and oversight, ensuring effective collaboration and performance of external partners.
Participate in the development of study protocols, informed consent forms, and other essential study documents, providing operational input and expertise.
Contribute to the preparation and review of regulatory submissions, safety reports, and other documentation as required.
Represent the organization at investigator meetings, sponsor meetings, and other external events, fostering effective communication and collaboration with study stakeholders.
Qualifications:
A minimum of 12-15 years of experience in clinical operations, with at least 7 years of dedicated global study management experience.
Preference will be given to candidates with experience from Japanese biotech or pharmaceutical companies.
Strong understanding of ICH/GCP guidelines, regulatory requirements, and industry best practices in clinical trial management.
Proven track record of successfully leading and managing complex, global clinical trials across various therapeutic areas.
Excellent communication, collaboration, and interpersonal skills, with the ability to effectively interact with cross-functional teams, vendors, and external stakeholders.
Proficiency in project management, risk management, and problem-solving skills.
Strong organizational skills, attention to detail, and the ability to multitask and prioritize in a fast-paced environment.
Proficiency in relevant software applications and clinical trial management systems.
Bachelor's degree in a scientific or related field; advanced degree in a relevant discipline is preferred.
Willingness and ability to commute to our office in New Jersey, as this is a hybrid role.
We offer a competitive compensation package and an opportunity to be part of a dynamic and innovative team dedicated to advancing healthcare solutions. If you possess the required qualifications and are passionate about contributing to the success of global clinical trials, we encourage you to apply for this exciting opportunity.
-
Senior Clinical Trial Manager
6 days ago
Trenton, United States i-Pharm Consulting Full timeJob Description: Senior Study ManagerWe are seeking an experienced and highly skilled Senior Study Manager to join our clinical operations team. This position requires a minimum of 12-15 years of experience in clinical operations, with at least 7 years of specialized experience in global study management.Responsibilities:Lead and oversee the operational...
-
Clinical Trial Manager
9 hours ago
Trenton, United States Shiftcodeanalytics Full timeCLINICAL TRIAL MANAGER 6+ MONTHS CONTRACT BASKING RIDGE, NJ / TARRYTOWN, NY HYBIRD (3 DAYS/WEEK) NEED IMMEDIATE JOINEE, START DATE Next week Monday VISA- NO CPT/H1B The Temp Senior Clinical Study Lead (CSL) Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical studies/research collaborations from study...
-
Project Manager
4 days ago
Trenton, United States CareerBuilder Full timeProject Manager (Clinical Endpoint/Adjudication) page is loaded **Project Manager (Clinical Endpoint/Adjudication)** **Project Manager (Clinical Endpoint/Adjudication)** locationsPrinceton, NJ time typeFull time posted onPosted 13 Days Ago job requisition idR8903 At Clario, we put people first, always. We are united and driven by patients, committed to...
-
Director/SD, Clinical Operations
1 week ago
Trenton, United States EPM Scientific Full timeTitle: Director/Senior Director, Clinical Operations Introductory Paragraph: We are looking for an exceptional candidate to join our client's mid-size immunology biotechnology company in central New Jersey. As the Director or Senior Director of Clinical Operations, you will be responsible for leading and managing clinical trials from Phase I through IV....
-
Clinical Study Lead
8 hours ago
Trenton, United States Shiftcodeanalytics Full timeCLINICAL STUDY LEAD 6+ MONTHS CONTRACT BASKING RIDGE, NJ / TARRYTOWN, NY HYBIRD (3 DAYS/WEEK) VISA- NO CPT/H1B The Temp Senior Clinical Study Lead (CSL) Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical studies/research collaborations from study design, through execution, to study close out....
-
Vice President of Clinical Operations
2 weeks ago
Trenton, United States i-Pharm Consulting Full timePosition Overview: As the Vice President of Clinical Operations, you will play a pivotal role in driving our client's clinical programs forward. You will be responsible for overseeing all aspects of clinical operations, from Phase I through Phase III trials. Your expertise in building and leading high-performing teams, coupled with your strategic oversight...
-
Senior Analyst/Programmer
2 weeks ago
Trenton, United States CareerBuilder Full timeResponsibilities: Overseeing SAS programming activities from varying aspects: programming, statistical and clinical Create, manage, and maintain the SAS programming algorithm for the clinical study database and data analysis Peer review the submission packages and contribute to the input of SAP and mock TFLs Perform ad hoc analyses to support Phase I to IV...
-
Vice President of Clinical Operations
Found in: Appcast Linkedin GBL C2 - 3 weeks ago
Trenton, United States i-Pharm Consulting Full timePosition Overview: As the Vice President of Clinical Operations, you will play a pivotal role in driving our client's clinical programs forward. You will be responsible for overseeing all aspects of clinical operations, from Phase I through Phase III trials. Your expertise in building and leading high-performing teams, coupled with your strategic oversight...
-
Vice President of Clinical Operations
2 days ago
Trenton, United States i-Pharm Consulting Full timePosition Overview: As the Vice President of Clinical Operations, you will play a pivotal role in driving our client's clinical programs forward. You will be responsible for overseeing all aspects of clinical operations, from Phase I through Phase III trials. Your expertise in building and leading high-performing teams, coupled with your strategic oversight...
-
Vice President of Clinical Operations
2 weeks ago
Trenton, United States i-Pharm Consulting Full timePosition Overview: As the Vice President of Clinical Operations, you will play a pivotal role in driving our client's clinical programs forward. You will be responsible for overseeing all aspects of clinical operations, from Phase I through Phase III trials. Your expertise in building and leading high-performing teams, coupled with your strategic oversight...
-
Medical Director Neurology
2 weeks ago
Trenton, United States Leaman Life Sciences Full timeThis is a new exciting opportunity to work for a global pharmaceutical company that is making significant progress and changes for patients worldwide who suffer from diseases related to Neurology. This role is for a Medical Director, a strategic role where you have control and oversight of medical affairs activities for Neurodegenerative disease products....
-
Trenton, United States CareerBuilder Full timeBiopharmaceutical company seeking a Senior Director, Marketing in Rare Disease. Company objective is to provide patients with therapeutic relief in serious diseases with high unmet medical need. We focus on clinical-stage programs based on molecules with a history of clinical use (well-established safety and tolerability) and either initial human activity or...
-
Senior Manager Application Development
5 days ago
Trenton, United States CVS Pharmacy Full timeJoin Fortune 7 CVS Health as a Sr. Manager of Application Development within the Shared Services and Advanced Technology Delivery (SSATD) organization. As an Applications Development Senior Manager, Pega Customer Decision Hub (CDH), you will collabor Manager, Application, Development, Senior, Retail
-
Tax Senior Manager
7 days ago
Trenton, United States Abacus Group Full timeOur client is a public accounting firm. You could be just the right applicant for this job Read all associated information and make sure to apply. They are looking for a Tax Senior Manager to join their Parsippany, NJ office.ResponsibilitiesObtain research findings, tax returns, and work papersReview implications and the best course of action for...
-
Manager/Sr. Manager
2 weeks ago
Trenton, United States CareerBuilder Full timeSummary This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with...
-
Associate Manager, Clinical Health Services
14 hours ago
Trenton, United States CVS Full timeThe Associate Manager of Clinical Health Services will oversee the implementation of healthcare management services for their assigned functional area. Fundamental Components Implements clinical policies & procedures in accordance with applicable reg Associate Manager, Clinical, Health, Manager, Associate, Clinic, Retail, Healthcare
-
Trenton, United States CVS Pharmacy Full timeThe Associate Manager of Clinical Health Services will oversee the implementation of healthcare management services for their assigned functional area. Fundamental Components Implements clinical policies & procedures in accordance with applicable reg Associate Manager, Clinical, Health, Manager, Associate, Clinic, Retail, Healthcare
-
Clinical Account Executive
2 weeks ago
Trenton, United States EmpiRx Health Full timeWho We Are: EmpiRx Health is the leading clinically-driven, customer-first PBM company that puts the pharmacist at the center of its service model to optimize member care while substantially reducing costs for plan sponsors. What We Do: We place more emphasis on member care than any other PBM by focusing on health outcomes first. Our pharmacists and...
-
Senior Product Manager
4 days ago
Trenton, United States Walmart Full timeWhat you'll do... Position: Senior Product Manager Job Location: 221 River Street, Hoboken, NJ 07030 Duties: Design and implement process to support supply chain flows based on new business strategies as we adapt to changing market conditions, new business opportunities, or cost reduction strategies. Define performance metrics for measurement, comparison,...
-
Senior Portfolio Manager
2 weeks ago
Trenton, United States The Judson Group Full timeReference Number: MHH7202 Location: Marlton, New Jersey Judson Group has partnered with a successful wealth management firm in the search for a Senior Portfolio Manager responsible for all necessary functions relating to the investment of client funds for the firm. This firm has a great reputation for serving its clients. The ideal candidate has extensive...