Clinical Trial Manager/Senior Clinical Trial Manager
2 weeks ago
Position Summary:
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the execution of clinical studies across our hematological and solid tumor programs. The ideal candidate should have experience in supporting the execution of oncology clinical studies as well as a working knowledge of ICH GCP regulations. The candidate should a enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
* Manage all aspects of clinical trials, specifically, study vendor management including CRO oversight, other study service providers involved in a clinical trial.
* Lead or support the cross-functional study execution team with study deliverables with focus on Clinical Operations deliverables to the study team.
* Triage CRO and clinical site questions.
* In conjunction with the legal team, facilitate the development of clinical trial agreements and other relevant documents.
* Coordinate and lead study team meetings and update timelines and milestones as needed.
* Train team members and site staff, including vendors, as needed.
* Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
* Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
* Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors
* Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies.
Requirements:
* BS/BA in scientific or healthcare discipline with 4-7 years experience in clinical trial management at a CRO, pharmaceutical/biotechnology company
* Experience with complex therapeutic platforms.
* Strong Oncology and Cell Therapy clinical trials.
* Strong computer skills, including Excel, Word, Outlook, and PowerPoint
* Knowledge of GCP guidelines and demonstrated experience supporting clinical trials
* Excellent interpersonal skills and ability to build strong professional relationships internally and externally
* Strong analytical and problem-solving skills
* Strong attention to detail in drafting materials, establishing priorities, scheduling, and meeting deadlines
About TScan:
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScans discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.
-
Senior Clinical Trials Manager
2 weeks ago
Waltham, United States Clinical Dynamix, Inc. Full timeGlobal Publicly Traded Pharmaceutical company is expanding.The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM / CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs....
-
Senior Clinical Trial Manager
17 hours ago
Waltham, United States Meet Full timeSenior Clinical Trial Manager - Oncology OR Gene Therapy experience REQUIRED Exciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or CTM (based on experience) motivated by science and excited to work in a biotech focused on oncology and genetically...
-
Senior Clinical Trial Manager
7 days ago
Waltham, United States Meet Full timeSenior Clinical Trial Manager - Oncology OR Gene Therapy experience REQUIREDExciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or CTM (based on experience) motivated by science and excited to work in a biotech focused on oncology and genetically...
-
Senior Clinical Trial Manager
2 days ago
Waltham, United States Meet Full timeSenior Clinical Trial Manager - Oncology OR Rare Disease experience REQUIREDExciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or AD (based on experience) motivated by science and excited to work in a biotech focused on oncology and rare...
-
Senior Clinical Trial Manager
3 days ago
Waltham, United States Meet Full timeSenior Clinical Trial Manager - Oncology OR Rare Disease experience REQUIREDExciting position has become available on a multi-disciplinary team of world class researchers and drug developers in a growing biotech searching for a Senior CTM or AD (based on experience) motivated by science and excited to work in a biotech focused on oncology and rare...
-
Waltham, United States TScan Therapeutics Full timeJob DescriptionJob DescriptionPosition Summary:TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the execution of clinical studies across our hematological and...
-
Clinical Trial Manager
2 weeks ago
Waltham, United States Alkermes Full timePosition Summary: Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I‐IV of development.
-
Senior Medical Director
4 weeks ago
Waltham, United States Clinical Dynamix Full timeResponsibilities:Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.Drives clinical strategy and leads...
-
Senior Manager, Clinical Operations
3 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description The Senior Manager Clinical Operations will provide line management to Clinical Trial Coordinators (CTCs), Clinical Trial Associates (CTAs) and Senior CTAs and will develop robust and flexible methodologies to optimize and harmonize the administrative and operational support provided to the clinical trial teams. What You’ll...
-
Senior Medical Director
2 weeks ago
Waltham, United States Clinical Dynamix, Inc. Full timeResponsibilities:Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.Drives clinical strategy and leads...
-
Waltham, United States Planet Pharma Full timeLocation: Waltham, MA - 3 days / week onsiteSalary: AD - $175K + 20% bonus; Director - $200K+ 22% BonusTop SkillsProven ability to lead Trial Master File (TMF) strategy, streamline processes, oversee vendor management, and ensure inspection readiness.Strong background in managing vendors effectively.Extensive experience with inspection readiness and...
-
Waltham, United States Planet Pharma Full timeLocation: Waltham, MA - 3 days / week onsiteSalary: AD - $175K + 20% bonus; Director - $200K+ 22% BonusTop SkillsProven ability to lead Trial Master File (TMF) strategy, streamline processes, oversee vendor management, and ensure inspection readiness.Strong background in managing vendors effectively.Extensive experience with inspection readiness and...
-
Waltham, United States Planet Pharma Full timeLocation: Waltham, MA - 3 days / week onsiteSalary: AD - $175K + 20% bonus; Director - $200K+ 22% BonusTop SkillsProven ability to lead Trial Master File (TMF) strategy, streamline processes, oversee vendor management, and ensure inspection readiness.Strong background in managing vendors effectively.Extensive experience with inspection readiness and...
-
Sr. Manager, Clinical Data Management
3 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Description We 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. Deciphera embraces a flexible workplace. You will work out of our Waltham, Massachusetts office....
-
Waltham, United States Planet Pharma Full timeJob Description:Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy. The TMF Associate Director/ Director will provide tactical support and strategic guidance on TMF processes, filing...
-
Waltham, United States Planet Pharma Full timeJob Description:Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy. The TMF Associate Director/ Director will provide tactical support and strategic guidance on TMF processes, filing...
-
Clinical Quality Manager
4 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance...
-
Clinical Quality Manager
1 month ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance...
-
Clinical Quality Manager
4 weeks ago
Waltham, United States BostonGene Full timePosition SummaryBostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements. The candidate will also be instrumental in quality assurance...
-
Waltham, United States Morphic Therapeutic Full timeAbout Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrdinger, Morphic is advancing its pipeline and discovery activities using...
