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 candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.



Reporting to the Director/Senior Director of Clinical Operations, the Clinical Trial Manager, Site Start-up is accountable for leading, directing and overseeing end-to-end start-up, site initiation and site activation in collaboration with key stakeholders across multiple complex studies in a fast-paced environment. The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams. The Clinical Trial Manager, Site Start-up role plays a significant contribution to the clinical trial execution and ability to meet the corporate study goals for the Company clinical programs. The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs.


This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule (3 days in the office and 2 days WFH).


Responsibilities (including, but not limited to):

Provides key data driven insights to study teams for study, country, and site feasibility along with start-up and enrollment forecasting.

Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies.

Prepare local and independent ethics committee submissions and responses to queries in collaboration with the cross functional team.

Prepare, distribute, and collect site-specific essential document packages. Clinical Trial Initiation Manager will deliver high quality and timely global study start-up. Manage study start-up planning, and modeling.

Oversee the informed consent process and translation of study required documents and participate in the development of study start up plans.

Coordinate contract and budget negotiations between sites and internal function team and coordinate investigational product release authorization with quality assurance.

Implement and monitor the progress of the study initiation plan and prepare and participate in project update meetings.

Creates, manages, and archives central startup team tools and resources required to support startup team daily operations, communications, and records from study assignment to final handoff.

Serves as a point of escalation for study teams and CROs for country and site activation issues.

Responsible for data driven assessment of country and site scenario planning, patient enrollment assumptions and start-up data.

Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities.

Partners with CRO to ensure effective start-up processes, utilizing appropriate technologies, as required, to deliver best in class country and site activation performance.

Provides internal expertise in the early planning of study start-up to ensure proposed CRO timelines and committed milestones are accurate and achievable.

Partners with Clinical Operations, Medical Affairs/local country offices to obtain local insights into country and site selection.


Qualifications:


  • BA/BS degree in Health or Life Sciences required, advanced degree preferred.
  • A minimum 5+ years of experience in Clinical Operations roles within the Pharmaceutical and/or Medical Device Industry, with heavy concentration within clinical trial management and monitoring.
  • Exceptional collaboration, communication, and interpersonal skills
  • Demonstrated ability to effectively manage external vendors & CROs
  • Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheets
  1. Demonstrated strong written and verbal communication skills
  2. Proven mindset of proactive continuous improvement
  3. Efficient independent worker with ability to focus and drive for results
  4. Strong attention to detail
  5. Ability to work in a fast paced-environment and to handle multiple tasks
  6. Strong commitment to ethical standards
  7. Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
  8. Ability to travel up to 10%
  9. The salary range for this position is commensurate with experience


Company offers a comprehensive benefits package including:

Competitive pay and stock options for all employees

Medical, dental, and vision coverage with 100% of premiums paid by Companyfor employees and their eligible dependents

Fertility and mental health programs

Short- and long-term disability coverage

Life, Travel and AD&D

401(k) Company Match with immediate company vest

Employee Stock Purchase plan

Generous vacation plan and paid company holiday shutdowns

Various mental, financial, and proactive physical health programs covered by Company

  • 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

    2 weeks ago

    Boston, MA, 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...

  • Project Manager

    3 weeks ago

    Boston, Massachusetts, United States Alliance for Clinical Trial in Oncology Foundation Full time

    About the RoleThe Alliance for Clinical Trials in Oncology Foundation is seeking a highly skilled Project Manager to join our team. As a key member of our Clinical Operations department, you will be responsible for managing the development, implementation, and oversight of assigned clinical trials.Key Responsibilities:Manage the development, implementation,...

  • Senior Clinical Trial Manager

    2 months 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...

  • Senior Clinical Trial Manager

    2 months 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, MA, 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...

  • Clinical Trial Operations Manager

    4 weeks ago

    Boston, Massachusetts, United States Aura BioSearch Full time

    Job SummaryAura BioSearch is seeking a seasoned Clinical Trial Manager to lead global early-phase clinical trials in a dynamic environment.The ideal candidate will have a strong background in clinical trial operations, with experience in managing trials from start-up to close-out, ensuring deliverables are met on time and within budget.Key...

  • Clinical Trial Manager

    1 week ago

    boston, United States Beacon Hill Full time

    Position Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related...

  • Clinical Trial Manager

    2 weeks ago

    Boston, United States Beacon Hill Full time

    Position Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related...

  • Clinical Trial Manager

    2 weeks ago

    boston, United States Beacon Hill Full time

    Position Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related...

  • Clinical Trial Manager

    1 week ago

    Boston, United States Beacon Hill Full time

    Position Overview: Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related...

  • Senior Clinical Trial Manager

    2 weeks ago

    Boston, United States Fairway Consulting Group Full time

    Our client is a biotechnology company developing treatments to target cancer. They have asked us to assist them in their search for a Senior Clinical Trial Manager. Major tasks and responsibilities include: Oversees assigned clinical trial(s) to ensure deliverables are met in all phases of trials. Oversees trial feasibility process and site feasibility and...

  • Clinical Trial Manager

    1 month ago

    Boston, United States Aura BioSearch Full time

    Clinical Trial Manager Boston We are working on behalf of our client to find a Clinical Trial Manager based in Boston to lead global earlyphase clinical trials in a dynamic environment. The role involves managing trials from startup to closeout ensuring deliverables are met on time and within budget. Key Responsibilities: Oversee clinical trials coordinating...

  • Clinical Trials Project Manager

    3 weeks ago

    Boston, Massachusetts, United States NuvoAir Full time

    Clinical Trials Project ManagerNuvoAir is seeking a highly skilled Clinical Trials Project Manager to join our team. As a Clinical Trials Project Manager, you will be responsible for managing multiple projects ranging in size and complexity from single to multi-center studies.Key Responsibilities:Manage multiple projects from start to finish, ensuring timely...

  • Clinical Trials Manager

    1 month ago

    Boston, Massachusetts, United States Aura BioSearch Full time

    Clinical Trial Manager OpportunityAura BioSearch is seeking a highly skilled Clinical Trial Manager to lead global early-phase clinical trials in a dynamic environment.Key Responsibilities:Oversee clinical trials, coordinating cross-functional teams to ensure smooth executionManage project timelines, track risks, and ensure communication across...

  • Senior Clinical Trial Manager

    2 weeks ago

    Boston, United States Aktis Oncology Full time

    Aktis Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted alpha radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital, the company has developed proprietary platforms to generate tumor-targeting agents with ideal properties for alpha radiotherapy. Designed...

  • Clinical Trial Associate

    4 weeks ago

    boston, United States Leaman Life Sciences Full time

    I am working with my client, a Gene Therapy Biotech based in Boston to find an exceptional Clinical Trial Associate as they expand their strong team within clinical operations.If you have passion for clinical research and come from a biotech background within Gene Therapy or Rare Disease/Neuromuscular this could be the role for you!This role requires someone...

  • Clinical Trial Associate

    1 month ago

    Boston, United States Leaman Life Sciences Full time

    I am working with my client, a Gene Therapy Biotech based in Boston to find an exceptional Clinical Trial Associate as they expand their strong team within clinical operations.If you have passion for clinical research and come from a biotech background within Gene Therapy or Rare Disease/Neuromuscular this could be the role for you!This role requires someone...

  • Clinical Trial Associate

    1 month ago

    Boston, United States Leaman Life Sciences Full time

    I am working with my client, a Gene Therapy Biotech based in Boston to find an exceptional Clinical Trial Associate as they expand their strong team within clinical operations.If you have passion for clinical research and come from a biotech background within Gene Therapy or Rare Disease/Neuromuscular this could be the role for you!This role requires someone...