Clinical Operations Manager for Efficient Trial Execution
1 day ago
Unlock Your Potential with Lifelancer
Sarepta Therapeutics is a leading company in the biotech industry, pushing the boundaries of genetic medicine. As a Clinical Operations Manager, you will play a crucial role in facilitating optimal clinical development operations, GCP compliance, and trial oversight.
Why Choose This Opportunity?
- This position offers the chance to participate in transformative initiatives that create effective and efficient processes, collaborating across Development Operations.
- You will drive Clinical Operations Excellence by managing oversight activities for cross-program monitoring oversight program.
- A key aspect of this role is providing subject matter expertise to facilitate optimal clinical development operations, GCP compliance, and trial oversight.
- The successful candidate will also be responsible for supporting compliance activities, including SOP activity and training compliance, as well as risk management/mitigation in accordance with the requirements of ICHE6(R2).
- This role requires strong organizational skills, attention to detail, and excellent communication skills to develop strong relationships with both internal and external customers.
About You
- Experience in supporting clinical trial GCP compliance/quality management activities is essential.
- Proficiency in CTMS systems and implementation/maintenance within the system is required.
- You must have excellent interpersonal and communication skills, as well as problem-solving, process improvement, analytical, and collaborative skills.
- The ideal candidate will have experience working independently, managing deadlines, and exercising managerial discretion.
Benefits and Compensation
We offer a competitive compensation package, including a salary range of $112,000 - $140,000 per year, depending on experience. In addition, we provide benefits such as physical and emotional wellness programs, financial wellness resources, and support for caregivers.
What's Next?
If you are a solution-oriented, critical thinker who is comfortable with ambiguity and candor, and you relish challenging yourself, we encourage you to apply. This position is remote, but you will be expected to work on site at one of Sarepta's facilities in the United States from time to time.
-
Clinical Operations Director
2 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeJob Description:We are seeking an experienced Clinical Operations Director to lead the management of late-stage clinical trials for our pharmaceutical company. This role will oversee the integration of project team activities, leveraging internal and development partner resources, expertise, and knowledge.About the Role:Provide strategic input and execution...
-
Lead Clinical Trials Manager
6 days ago
Cambridge, Massachusetts, United States Boston Pharmaceuticals Full timeJob DescriptionBoston Pharmaceuticals is a clinical-stage biopharmaceutical company with a strong focus on developing innovative targeted therapies for serious liver diseases. We are currently seeking an experienced Sr. Clinical Trial Manager to support the management and progression of all our clinical programs.Key Responsibilities:Manage contract research...
-
Clinical Operations Excellence Manager
6 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout Sarepta Therapeutics">Sarepta Therapeutics is a leading biotech company focused on developing innovative treatments for rare genetic diseases. Our mission is to bring hope and healing to patients and families affected by these devastating conditions.Job Summary">We are seeking an experienced Clinical Operations Excellence Manager to join our team. This...
-
Clinical Operations Excellence Manager
2 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout Sarepta TherapeuticsSarepta Therapeutics is a leader in genetic medicine, pioneering innovative treatments for rare diseases such as Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs). With a strong commitment to patient care and community support, we strive to maintain a culture that acknowledges the importance of work-life...
-
Clinical Trial Master File Specialist
2 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Clinical Trial Master File SpecialistAbout the Role:We are seeking a highly skilled Clinical Trial Master File Specialist to join our growing team at Bicycle Therapeutics. As a Clinical Trial Master File Specialist, you will be responsible for supporting the development and implementation of our eTMF system, ensuring that our clinical trial...
-
Research Scientist
1 week ago
Cambridge, Massachusetts, United States Cullinan Therapeutics Full timeAbout Cullinan TherapeuticsCullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to advancing new standards of care for patients. Our portfolio encompasses a wide range of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease.Job Description:We...
-
Senior Clinical Operations Leader
7 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Operations Leader to join our team at Alnylam Pharmaceuticals. This is an exciting opportunity for a motivated and experienced professional to lead clinical studies and drive operational excellence in drug development.Job DescriptionThe successful candidate will be responsible for leading...
-
Director of Clinical Operations Excellence
2 weeks ago
Cambridge, Massachusetts, United States Lifelancer Full timeOverviewSarepta Therapeutics is a leading biotechnology company dedicated to delivering life-changing therapies for patients with rare genetic disorders. We are committed to pushing the boundaries of innovation and making a meaningful impact on people's lives.SalaryThe estimated salary range for this position is $112,000 - $140,000 per year. This...
-
Clinical Operations Excellence Specialist
7 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeCompany OverviewSarepta Therapeutics is a pioneer in genetic medicine, holding leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs). With over 40 programs in various stages of development, the company is at the forefront of gene therapy, RNA, and gene editing. Sarepta's commitment to patients and dedication...
-
Clinical Contract Negotiator
6 days ago
Cambridge, Massachusetts, United States Integrated Resources, Inc ( IRI ) Full timeWe are seeking a skilled Clinical Contract Manager to join our team at Integrated Resources, Inc (IRI) in Cambridge, MA.About the RoleThis is a global R&D level position focusing on supporting the Global Clinical Development Operations (CDO) function as part of the CDO Business Strategy & Operations group. The successful candidate will manage and facilitate...
-
Cambridge, Massachusetts, United States Maxis Clinical Sciences Full timeAbout the RoleAs a Senior Biostatistician at Maxis Clinical Sciences, you will be leading the statistical development strategy for our therapeutic antibodies. This is an exciting opportunity to leverage your expertise in drug development and biostatistics to drive innovation in clinical trials.Key ResponsibilitiesDevelop and implement statistical strategies...
-
Senior Clinical Operations Manager
7 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeAbout the JobWe are seeking a highly skilled Senior Clinical Operations Manager to join our team at Lifelancer. As a key member of our operations team, you will be responsible for leading and managing clinical studies from start to finish.Key Responsibilities:Lead and manage integration of all project team activities, leveraging internal and development...
-
Senior Clinical Contracts Manager
3 days ago
Cambridge, Massachusetts, United States Integrated Resources, Inc ( IRI ) Full timeAbout the RoleWe are seeking an experienced Senior Clinical Contracts Manager to join our team at Integrated Resources, Inc. (IRI). As a key member of our Global Clinical Development Operations group, you will play a critical role in supporting our clinical trial excellence strategy by managing and facilitating the management of clinical trial/clinical...
-
Clinical Operations Study Start-up Director
4 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeJob DescriptionWe are seeking a highly skilled Clinical Operations Study Start-up Director to join our team at Lifelancer. As a key member of our organization, you will be responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery.About the Role:Develop and deliver the global study startup plan by...
-
Regional Clinical Study Management Lead
4 days ago
Cambridge, Massachusetts, United States Lifelancer Full timeJob Summary:We are seeking a seasoned Clinical Study Management Lead to join our team at Lifelancer. As a key member of our clinical operations team, you will play a pivotal role in managing and leading cross-functional teams to deliver high-quality clinical trials.Key Responsibilities:Line Management:Lead and manage Clinical Trial Management Associate...
-
Clinical Contract Professional
5 days ago
Cambridge, Massachusetts, United States Integrated Resources, Inc ( IRI ) Full timeAbout the RoleWe are seeking a highly skilled Clinical Contract Professional to join our team at Integrated Resources, Inc (IRI). As a key member of our organization, you will play a critical role in managing clinical trial/clinical project-related contracts.Key ResponsibilitiesDraft, evaluate, negotiate, execute & archive Clinical trial/Clinical...
-
Transformative Clinical Expert
4 weeks ago
Cambridge, Massachusetts, United States Bristol Myers Squibb Full timeBristol Myers Squibb is at the forefront of transforming patients' lives through science, and we are seeking a highly skilled Clinical Scientist to join our team. As a key member of our clinical operations team, you will be responsible for designing and executing assigned clinical trial activities, collaborating with cross-functional teams, and ensuring the...
-
Clinical Document Management Specialist
6 days ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeWe are seeking a skilled Clinical Document Management Specialist to join our team at Proclinical Staffing in Cambridge, MA. As a Clinical Document Management Specialist, you will play a critical role in ensuring the accuracy and timeliness of clinical documents, including Trial Master Files (TMFs). You will be responsible for managing clinical document...
-
Cambridge, Massachusetts, United States Bristol Myers Squibb Full timeUnlock Meaningful Careers at Bristol Myers SquibbBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. With a single vision, we strive to make a difference in the lives of those affected by serious diseases.About the RoleWe are seeking an exceptional Clinical Development Lead to join our team. As...
-
Senior Data Management Director
6 days ago
Cambridge, Massachusetts, United States Prometrika LLC Full timeJob OverviewPrometrika LLC is a leading clinical research organization with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for delivering high-quality results and our commitment to fostering a collaborative work environment.About the RoleWe're seeking an...