Clinical Trial Operations Manager
4 days ago
Abata Therapeutics is a pioneering biotechnology company dedicated to developing innovative therapies for autoimmune diseases. Our mission is to transform lives by harnessing the power of regulatory T cells (Tregs) to restore homeostasis and promote durable responses in patients with Multiple Sclerosis and Type 1 Diabetes.
The RoleWe are seeking a highly skilled Clinical Trial Manager to oversee the execution of our clinical studies. This is a temporary position with the potential for permanent placement in the future. As a Clinical Trial Manager, you will be responsible for developing and implementing operational plans, managing clinical vendors, and coordinating with internal cross-functional teams to ensure the successful delivery of our clinical studies.
Key Responsibilities- Oversee the day-to-day operations of study execution, including study document creation, enrollment, monitoring, data cleaning, and clinical site interactions.
- Collaborate with a dynamic Abata cross-functional team to deliver clinical studies on time and within budget, while ensuring quality in accordance with the protocol and ICH GCP guidelines.
- Coordinate with technical operations, vendors, and sites to facilitate patient apheresis collection scheduling and supply chain logistics.
- Ensure reliable quality data are delivered by reviewing monitoring reports, protocol deviations, and attending or overseeing site monitoring visits.
- Support the Clinical Development Operations and the greater Clinical Development organization by identifying and implementing process improvements and efficiencies across programs.
- Demonstrated ability to achieve high competency in the key responsibilities of the job description. Bachelor's Degree in a scientific or clinical discipline is required.
- Ability and interest in tactical implementation as well as higher-level strategic responsibilities.
- Experience with a biotechnology/pharmaceutical company is required, with small biotech experience preferred. Experience with a CRO may be considered part of the clinical operations experience.
- Early phase clinical trial experience is required, with cell therapy experience preferred.
- Strong project management and multi-functional team leadership skills, including interpersonal communication, verbal and written communication, organizational aptitude, and attention to detail.
- Travel 10-20% including visits to investigational sites.
We are an equal opportunity employer offering a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the US.
This is an on-site position based in the Watertown, MA office and the employee will be required to work in the office on a regular basis. Abata Therapeutics will require compliance with our COVID-19 vaccination policy.
-
Clinical Trial Operations Manager
13 hours ago
Watertown, Massachusetts, United States Affini-T Full timeAbout Affini-T TherapeuticsA clinical stage biotechnology company focused on building a best-in-class TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop solid tumor therapies.Job SummaryIn a highly collaborative environment, the Clinical Trial Manager will play an essential...
-
Clinical Trial Operations Manager
8 hours ago
Watertown, Massachusetts, United States Abata Therapeutics Full timeAbout UsAbata Therapeutics is a biotechnology company dedicated to developing innovative therapies for autoimmune diseases. Our mission is to transform lives by providing cures for Multiple Sclerosis and Type 1 Diabetes.The RoleWe are seeking a talented Clinical Trial Manager to oversee our clinical studies. This role will be responsible for the development...
-
Senior Clinical Trial Manager
4 days ago
Watertown, Massachusetts, United States Treeline Biosciences Full timeSenior Clinical Trial ManagerWe are seeking a highly experienced Senior Clinical Trial Manager to join our Clinical Development team at Treeline Biosciences. This role will be responsible for providing trial management support for our oncology programs, ensuring compliance with regulatory requirements and internal SOPs.Key Responsibilities:Manage clinical...
-
Senior Clinical Trial Manager
5 days ago
Watertown, Massachusetts, United States Meet Full timeSenior Clinical Trial ManagerWe are seeking a highly skilled Senior Clinical Trial Manager to lead our Clinical Development team in oncology programs. This role involves preparing study materials, tracking enrollment, managing relationships with study sites and vendors, and overseeing study activities to ensure compliance with ICH/GCP and regulatory...
-
Senior Clinical Trial Manager
4 weeks ago
Watertown, Massachusetts, United States Meet Full timeSenior Clinical Trial ManagerWe are seeking a highly experienced Senior Clinical Trial Manager to lead our Clinical Development team in oncology programs. This role involves preparing study materials, tracking enrollment, managing relationships with study sites and vendors, and overseeing study activities to ensure compliance with ICH/GCP and regulatory...
-
Senior Clinical Trial Manager
3 weeks ago
Watertown, Massachusetts, United States Meet Full timeMeet Our TeamWe are seeking a highly skilled and experienced Senior Clinical Trial Manager to join our Clinical Development team, focusing on oncology programs. This role, reporting to the VP of Clinical Operations, involves preparing study materials, tracking enrollment, managing relationships with study sites and vendors, overseeing study activities, and...
-
Clinical Operations Director
3 weeks ago
Watertown, Massachusetts, United States Crescent City Recruitment Group Full timeJob Title: Director, Clinical OperationsCrescent City Recruitment Group is seeking a highly experienced Director, Clinical Operations to join our team. As a key member of our clinical development team, you will be responsible for overseeing and managing all aspects of clinical operations for a high-priority immunology program.Key Responsibilities:Develop and...
-
Clinical Operations Director
3 days ago
Watertown, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Title: Director, Clinical OperationsStratacuity is seeking a seasoned Director, Clinical Operations to lead the clinical trial operations for their immunology program across all phases (I-III). This role will ensure successful collaboration and team management, driving the program's goals and progress.Key Responsibilities:Lead clinical trial execution...
-
Clinical Operations Director
4 weeks ago
Watertown, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Title: Director, Clinical OperationsLocation: Remote/HybridJob Type: Full-timeIndustry: BiopharmaceuticalAbout Stratacuity:Stratacuity is a leading provider of scientific placement services, connecting top talent with innovative biopharmaceutical companies. Our team is dedicated to building lasting relationships and protecting your personal...
-
Clinical Operations Director
3 weeks ago
Watertown, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Title: Clinical Operations DirectorLocation: HybridTherapeutic Area: AutoimmuneJob Overview: Stratacuity is seeking a highly experienced Clinical Operations Director to lead the clinical trial operations for their immunology program across all phases (I-III). The successful candidate will ensure successful collaboration and team management.Primary Job...
-
Clinical Operations Director
3 weeks ago
Watertown, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob Title: Director, Clinical OperationsStratacuity is seeking a highly experienced Director, Clinical Operations to lead the clinical trial operations for their immunology program across all phases (I-III). The successful candidate will ensure successful collaboration and team management, driving the program towards its goals.Key Responsibilities:Lead...
-
Senior Manager, Clinical Data Management
3 days ago
Watertown, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob DescriptionWe are seeking a Senior Manager to lead Clinical Data Management (CDM) activities for clinical studies or clinical program(s). This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office.Key Responsibilities:May simultaneously function as lead CDM for multiple clinical trials or oversee the...
-
Clinical Diagnostic Operations Manager
3 days ago
Watertown, Massachusetts, United States AbbVie Full timeAbout the RoleAbsorb the opportunity to lead the implementation of clinical diagnostic strategies for therapeutic programs in early and late stage oncology clinical development at AbbVie.This role requires a highly motivated individual to work closely with CDx Strategy Leads and other clinical development team members to facilitate science-based CDx decision...
-
Clinical Supply Chain Manager
4 weeks ago
Watertown, Massachusetts, United States Alkermes Full timeJob DescriptionAlkermes is seeking a highly skilled Clinical Supply Chain Manager to lead end-to-end supply chain management for single to multiple clinical programs. The successful candidate will work closely with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel to ensure seamless...
-
Senior Manager, Clinical Data Management
3 weeks ago
Watertown, Massachusetts, United States C4 Therapeutics Inc Full timeAbout C4 TherapeuticsC4 Therapeutics is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives. Our team is passionate about developing innovative treatments for difficult-to-treat diseases, and we're looking for a...
-
Clinical Research Director
3 days ago
Watertown, Massachusetts, United States Dragonfly Therapeutics, Inc. Full timeJob Title: Director, Clinical Research ScientistDragonfly Therapeutics is seeking a highly skilled Clinical Research Scientist to lead the implementation, planning, and execution of clinical trial activities. As a key member of our clinical development team, you will be responsible for delivering high-quality trial execution, investigator engagement, data...
-
VP Clinical Development Lead
6 hours ago
Watertown, Massachusetts, United States Affini-T Full timeAbout Affini-T Therapeutics Affini-T Therapeutics is a clinical-stage biotechnology company focused on building a "best-in-class" TCR therapy platform. Our innovative method of discovering high-affinity TCRs specific to oncogenic driver mutations is used to develop solid tumor therapies. Through the application of gene editing and synthetic biology, we focus...
-
Service Contract Manager
5 days ago
Watertown, Massachusetts, United States FRESENIUS MEDICAL CENTER Full timePurpose and ScopeThe Contract Administration Manager plays a critical role in the business by overseeing the contracting process for clinical trials, including the management of agreements and related documents.This position is responsible for the successful implementation, coordination, and administration of contracting procedures for clinical trial...
-
Clinical Operations Manager
22 hours ago
Watertown, Massachusetts, United States OI Infusion Full timeAbout OI Infusion ServicesAt OI Infusion Services, we're dedicated to providing exceptional, compassionate care to patients through comprehensive infusion therapy services. We're seeking a skilled Nurse Practitioner to manage and operate their own small infusion centers, working closely with physicians to ensure the best standard of care at the point of...
-
Watertown, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Title: Senior Manager, Pharmacovigilance OperationsDeciphera Pharmaceuticals is seeking a highly skilled and experienced Senior Manager, Pharmacovigilance Operations to join our team. As a key member of our Pharmacovigilance department, you will be responsible for providing direction and oversight to ensure the efficient and compliant management of...