Clinical Trial Manager/Senior Clinical Trial Manager

1 week ago

Waltham, United States TScan Therapeutics Full time
Job DescriptionJob Description

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. TScan’s 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.

  • Clinical Trial Manager/Senior Clinical Trial Manager

    9 hours ago

    Waltham, United States TScan Therapeutics Full time

    Job 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...

  • Senior Medical Director

    1 week ago

    Waltham, United States Clinical Dynamix Full time

    Responsibilities: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 Medical Director

    1 day ago

    Waltham, United States Clinical Dynamix Full time

    Responsibilities: 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...

  • Senior Manager, Clinical Operations

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job 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...

  • Sr. Manager, Clinical Data Management

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job 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....

  • Manager / Sr. Manager, Clinical Data Management

    1 week ago

    Waltham, United States Q32 Bio Inc. Full time

    General Scope and SummaryQ32 Bio is searching for a Clinical Data Manager/Sr. Manager responsible for timely and high-quality data management/analytics deliverables. Our Clinical Data Manager/Sr. Manager will also be responsible for leading or contributing to company process improvement initiatives, vendor performance assessments and governance of clinical...

  • Manager / Sr. Manager, Clinical Data Management

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Waltham, United States Q32 Bio Inc. Full time

    General Scope and SummaryQ32 Bio is searching for a Clinical Data Manager/Sr. Manager responsible for timely and high-quality data management/analytics deliverables. Our Clinical Data Manager/Sr. Manager will also be responsible for leading or contributing to company process improvement initiatives, vendor performance assessments and governance of clinical...

  • Manager / Sr. Manager, Clinical Data Management

    1 day ago

    Waltham, United States Q32 Bio Inc. Full time

    General Scope and SummaryQ32 Bio is searching for a Clinical Data Manager/Sr. Manager responsible for timely and high-quality data management/analytics deliverables. Our Clinical Data Manager/Sr. Manager will also be responsible for leading or contributing to company process improvement initiatives, vendor performance assessments and governance of clinical...

  • Manager / Sr. Manager, Clinical Data Management

    Found in: Appcast Linkedin GBL C2 - 1 day ago

    Waltham, United States Q32 Bio Inc. Full time

    General Scope and SummaryQ32 Bio is searching for a Clinical Data Manager/Sr. Manager responsible for timely and high-quality data management/analytics deliverables. Our Clinical Data Manager/Sr. Manager will also be responsible for leading or contributing to company process improvement initiatives, vendor performance assessments and governance of clinical...

  • Clinical Quality Manager

    Found in: Appcast US C2 - 1 week ago

    Waltham, United States BostonGene Full time

    Position 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

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Waltham, United States BostonGene Full time

    Position 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 week ago

    Waltham, United States BostonGene Full time

    Position 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...

  • SVP, Head of Clinical Development

    Found in: beBee S US - 2 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Manager, Clinical Data Management

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. 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. Deciphera...

  • SVP, Head of Clinical Development

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Manager, GCP Clinical QA

    Found in: Talent US C2 - 2 weeks ago

    Waltham, United States Precision Life Sciences Full time

    Job Description: Manager, GCP Clinical QAOur client’s Clinical Quality team is growing, and we are currently recruiting for a Manager/Sr. Manager of GCP Clinical Quality Assurance. The Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials. They will lead and/or support GCP...

  • Associate Director, Clinical Scientist

    Found in: beBee S US - 2 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Associate Director, Clinical Scientist

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Clinical Programmer

    1 week ago

    Waltham, United States LLX Solutions Full time

    We have an immediate opening for an entry-level Clinical Programmer.The Clinical Programmer is responsible for performing clinical programming activities for assigned clinical studies. This is a full time on-site position with great career development and advancement opportunities.Responsibilities:Conduct clinical programming to support clinical data...

  • Clinical SAS Programmer

    1 week ago

    Waltham, United States LLX Solutions Full time

    Responsibilities: Conduct clinical programming to support clinical data management, data cleaning, and data review, as well as external data reconciliation in accordance with standards (CDISC, MedDRA, WHO-DD, FDA)/SOPs or study specific guidelines Work with Data Manager to generate and review database specification documents, CRF specifications, edit...