SENIOR CLINICAL TRIAL MANAGER
2 weeks ago
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.
-
Berkeley Heights, NJ, United States Bristol-Myers Squibb Full timeAt Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human...
-
PRINCETON, NJ, United States ascendis pharma Full timeDescriptionHere at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we’re advancing programs in Endocrinology Rare Disease, and Oncology. Guided by our core values of patients, science,...
-
East Hanover, NJ, United States Novartis Full timeJob Description766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.Responsible for providing operational expertise in the mobilization of the organization’s commitment to sharing of clinical trial documentation and datasets; to...
-
Trial Management Director
3 days ago
Titusville, NJ, United States Johnson & Johnson Full timeDescriptionDirector, Trial ManagementJohnson & Johnson Innovative Medicine is recruiting for a Director, Trial Management (Medical Affairs Delivery Unit) to be located in the US (Horsham, PA; La Jolla, CA; Raritan, NJ; Spring House, PA; Titusville, NJ), Europe (Basel, CH; Beerse BE; High Wycombe, UK; Cork, IE; Leiden, NL), or Asia (China, Japan Singapore).At...
-
Miami, FL, United States Baptist Health South Florida Full timeThe Clinical Trials Nurse effectively conducts assigned operations of research protocols. Coordinates, evaluates and follows patient participation in clinical trials. Performs protocol specific clinical tasks including patient assessment, screening, ordering tests, collecting specimens and monitoring responses to the investigational treatment. Implement the...
-
Clinical Trial Site Payments Manager
6 days ago
PRINCETON, NJ, United States Bristol-Myers Squibb Full timeAt Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human...
-
WCI CLINICAL TRIALS OFFICE-RESEARCH
2 weeks ago
, NY, United States University of Rochester Full timeResponsibilitiesThe WCI Clinicals Trials Office (CTO) is seeking a highly motivated and inclusive individual to become a part of our leadership team. This is a great opportunity to mentor and work collaboratively with staff (both nurses and study coordinators) to further develop our clinical trials team within the CTO. This role provides oversight for the...
-
WCI Clinical Trials Office-Research
1 day ago
Rochester, NY, United States University of Rochester Full timeResponsibilities The WCI Clinicals Trials Office (CTO) is seeking a highly motivated and inclusive individual to become a part of our leadership team. This is a great opportunity to mentor and work collaboratively with staff (both nurses and study coordinators) to further develop our clinical trials team within the CTO. This role provides oversight for the...
-
Senior Manager, Statistical Programming
7 days ago
Parsippany, NJ, United States Planet Pharma Full timeSummary: The Senior Manager-Statistical Programming, a hands-on with expert-level programmer in SAS and SQL, will lead in programming, managing and analyzing commercial administrative databases, registry cohort, observational studies, and clinical trial studies. The candidate is responsible for programming in numerous data processing steps (cleaning,...
-
Jr. Clinical Data Manager
1 month ago
NJ, United States TruMinds Technologies Full timeCandidates with 0years experience may also apply training will be provided.Remote Training and Remote positions available• Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes. • Investigate and resolve data anomalies. • Identify the need for and...
-
Associate Manager, Clinical Study
2 days ago
Armonk, NY, United States Regeneron - Willhire Full timeAssociate Manager, Clinical StudyBudgetCase ReportClinical MonitoringClinical StudyClinical TrialCRFDatabaseData ManagementData QualityForecastingReconciliationTrial ManagementDescription:Associate Manager, Clinical StudyPay Range: $50.92 - $83.27/hrHybrid Role in Armonk, NYThe Temp Assoc Mgr Clinical Study will be assigned activities by the CSL,...
-
Wilmot Cancer Center
1 day ago
Rochester, NY, United States University of Rochester Full timeResponsibilities Seeking a team focused professional with a passion for oncology. This is an exciting opportunity to join the Clinical Trials Office as part of the Wilmot Cancer Center (WCC) within the University of Rochester Medical Center (URMC) as a Clinical Research Nurse (CRN). The CRN works closely with and is guided by the Principal Investigator, to...
-
Trial Attorney
4 weeks ago
Conley, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
4 weeks ago
Decatur, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
4 weeks ago
Smyrna, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
1 month ago
Tucker, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
7 days ago
Atlanta, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
7 days ago
Clarkston, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
6 days ago
Mableton, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
-
Trial Attorney
4 weeks ago
morrow, GA, United States State Farm Full timeOverviewWe are not just offering a job but a meaningful career! Come join our passionate team!As a Fortune 50 company, we hire the best employees to serve our customers, making us a leader in the insurance and financial services industry. State Farm embraces diversity and inclusion to ensure a workforce that is engaged, builds on the strengths and talents of...
