Current jobs related to Senior Clinical Study Manager - Boston - BiotechPharma

  • Senior Clinical Trial Manager

    4 weeks ago

    Boston, United States Clinical Dynamix Full time

    Senior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...

  • Senior Clinical Trial Manager

    2 weeks ago

    boston, United States Clinical Dynamix Full time

    Senior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...

  • Senior Clinical Trial Manager

    4 weeks ago

    Boston, United States Clinical Dynamix Full time

    Senior Clinical Trial ManagerDescriptionReporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with...

  • Associate Director, Clinical Data Management

    4 weeks ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    2 months ago

    boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    4 weeks ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    5 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    5 months ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Clinical Trial Manager, Start Up

    2 months ago

    Boston, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Clinical Trial Manager, Start Up

    4 weeks ago

    Boston, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Clinical Trial Manager, Start Up

    1 month ago

    boston, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Clinical Trial Manager, Start Up

    2 months ago

    Boston, United States Clinical Dynamix Full time

    Clinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...

  • Senior Clinical Trial Manager

    6 days ago

    Boston, Massachusetts, United States X4 Pharmaceuticals Full time

    Senior Clinical Trial ManagerX4 Pharmaceuticals is seeking a highly skilled Senior Clinical Trial Manager to join our Clinical Operations team. As a key member of our team, you will play a crucial role in the day-to-day management and execution of clinical trials.Key Responsibilities:Manage and oversee clinical trial operations, including CRO and third-party...

  • Senior Clinical Research Program Manager

    4 weeks ago

    Boston, Massachusetts, United States Massachusetts General Hospital(MGH) Full time

    Job Title: Senior Clinical Research Program ManagerMassachusetts General Hospital (MGH) is seeking a highly skilled and experienced Senior Clinical Research Program Manager to join our research team. The successful candidate will be responsible for leading a portfolio of quantitative and qualitative research projects, developing and prioritizing new...

  • Senior Clinical Data Manager

    4 weeks ago

    Boston, Massachusetts, United States KCR Full time

    Job Title: Senior Clinical Data ManagerWe are seeking an experienced Senior Clinical Data Manager to join our team at KCR. As a Senior Clinical Data Manager, you will play a critical role in advancing drug and vaccine development programs by overseeing all aspects of data management activities.Key Responsibilities:Lead, plan, and execute data management...

  • Senior Clinical Research Program Manager

    1 month ago

    Boston, Massachusetts, United States Massachusetts General Hospital(MGH) Full time

    Job Title: Senior Clinical Research Program ManagerWe are seeking a highly skilled and experienced Senior Clinical Research Program Manager to join our team at Massachusetts General Hospital (MGH). The successful candidate will be responsible for leading a portfolio of quantitative and qualitative research projects, developing and prioritizing new...

  • Senior Biostatistician

    2 weeks ago

    Boston, United States Piper Companies Full time

    Piper Companies is currently seeking an experienced Biostatistician to join a well-established, global clinical research organization focused on improving the drug development process and access to therapeutics. The role is mostly remote with some hybrid responsibilities when necessary. Die to this the candidate must be located in the Boston, MA...

  • Clinical Project Manager

    1 month ago

    Boston, United States Albion Rye Associates Full time

    Job Title: Clinical Project Manager Location: Boston, MA Company: Rare Disease Biotech Employment Type: Full-time   Position Summary: Our client are an innovative biotech company focused on developing breakthrough therapies for rare diseases, is seeking a dynamic and experienced Clinical Project Manager (CPM) to lead and manage early-phase...

  • Clinical Project Manager

    1 month ago

    Boston, United States Albion Rye Associates Full time

    Job Title: Clinical Project ManagerLocation: Boston, MACompany: Rare Disease BiotechEmployment Type: Full-timePosition Summary:Our client are an innovative biotech company focused on developing breakthrough therapies for rare diseases, is seeking a dynamic and experienced Clinical Project Manager (CPM) to lead and manage early-phase clinical trials. This...

  • Clinical Project Manager

    4 weeks ago

    Boston, United States Albion Rye Associates Full time

    Job Title: Clinical Project ManagerLocation: Boston, MACompany: Rare Disease BiotechEmployment Type: Full-timePosition Summary:Our client are an innovative biotech company focused on developing breakthrough therapies for rare diseases, is seeking a dynamic and experienced Clinical Project Manager (CPM) to lead and manage early-phase clinical trials. This...

Senior Clinical Study Manager

2 months ago

Boston, United States BiotechPharma Full time

Clinical / Senior Clinical Study Manager – Onsite, Boston MA

Hybrid, MUST BE ONSITE 2 days per week. No relocation for this role, MUST be local.


Expanding late stage biotech working in the Kidney disease areas looking to expand.

This position is focused on the development of a cell therapy to change the treatment for Kidney Disease. They are looking for candidates who have at least 4 years of clinical operations experience within a Pharmaceutical or Biotech environment, managing all aspects of studies and overseeing CRO partners (strong vendor Management experience highly desired). Must have Phase III experience. This position requires a solid understanding of clinical drug development, GCP and familiarity with regulatory requirements for the conduct of clinical trials.


Description:

Senior Clinical Study Manager, Clinical Operations will be responsible for the successful execution of clinical trials from protocol finalization through closeout.

Collaborate with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study initiatives

Management of the CRO’s contracted scope and services (regulatory, site management, etc.) to ensure quality, timely performance and accountability for agreed responsibilities, timelines, quality and budgets.

Regularly communicate trial status, issues, and mitigations to relevant cross-functional stakeholders. Proactively identify project risks and resolution

Develop study specific plans including key milestones, objectives and timelines and ensure country and site feasibility and selection.

Participate in the development and testing of clinical systems (e.g., data capture, IxRS)

Ensure internal and external systems are updated in a timely manner (e.g., internal and study trackers, clinicaltrials.gov)

Manage critical study documents, such as consent forms, study manuals, subject recruitment materials

Oversee the Trial Master File (TMF) and assist with the periodic audits of the TMF

Drive critical clinical trial activities including site activations, recruitment, and database lock

Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting

Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science, QA team members etc., both internally and externally including our CRO Partners, to ensure ongoing performance alignment

Participate in the development of tools and the reporting of metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points.

Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation

Provide input in internal/external study related audits, review resulting reports and ensure appropriate mitigations and follow up

Help review monitoring reports and, if applicable, drive corrective action site plans and provide oversight to ensure safety concerns etc. are identified and responses implemented

Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards

Train study team members, external monitors, and site staff as needed


Required:

Bachelor’s degree in a scientific discipline is required

4+ years clinical operations experience working for a pharmaceutical or biotech company (no CRO’s)

3+ years experience as a Senior Clinical Study Manager or Clinical Trial Manager is a MUST

Phase III-VI trials experience is a MUST

Experience with global clinical trial operations, in multiple phases of research, including late stage

Strong knowledge of ICH guidelines, GCP and FDA regulations

Experience with all aspects of trial and site startup and vendor management and oversight

Experience in rare disease, pediatric, and/or complex clinical trials preferred

Very strong oral and written communication skills

Ability to find creative solutions to issues impacting timelines and budgets

***Position pays up to $170,000 base (depending on experience) plus 15% bonus & stock***