Clinical Trial Manager

4 days ago


Waltham, United States Royalty Staffing Full time $130,000 - $155,000
The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule (Must be in the Waltham office 2-3 days per week). Remote work is allowed, and the frequency is at the discretion of management.
Responsibilities:
  • Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
  • Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
  • Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
  • Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
  • Project leadership of the cross-functional study team, including external team members, CROs and vendors.
  • Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
  • Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
  • May provide technical advice to team members.
  • Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
  • Interact with clinical research investigators, Key Opinion Leaders and sites.
  • Interact with Senior Management to report on progress of milestones.
  • Oversight of study team and site training
  • Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
  • Management of study drug distribution and accountability processes and documentation
  • Oversight of study start-up, study management, data cleaning, and study closeout activities
  • Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
  • Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.

Requirements:
  • BA/BS degree in Health or Life Sciences required, advanced degree preferred
  • A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
  • Exceptional communication and interpersonal skills
  • Positive team orientated attitude
  • Must speak fluent English if it is their second language
  • Advanced proficiency in Microsoft Office and Microsoft Project
  • Reliable, self-motivated, team player
  • Detail oriented with excellent organizational skills
  • Ability to effectively manage multiple tasks and competing priorities
  • Creative problem solver


About Royalty Staffing:



  • Waltham, United States Clinical Dynamix, Inc. Full time

    The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office...


  • Waltham, Massachusetts, United States Clinical Dynamix, Inc. Full time

    The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office...


  • Waltham, Massachusetts, United States Clinical Dynamix, Inc. 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...


  • Waltham, United States Clinical Dynamix, Inc. 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...

  • Data Strategy Lead

    4 days ago


    Waltham, Massachusetts, United States Clinical Dynamix Full time

    Data Strategy Lead - Clinical TrialsAs a Senior member of our Clinical Data Management team, the Associate Director, Clinical Data Management will play a critical role in defining and leading the clinical data management strategy for Clinical Dynamix. This includes overseeing the start-up and execution of multiple complex trials with CROs, ensuring data...


  • Waltham, United States GQR Full time

    Clinical Trial Manager, Site Start-Up Location: Waltham, MA (3 days on-site) Will Consider Remote EAST COAST ONLY Department: Clinical OperationsAbout the RoleOur client, an innovative biotech company, is seeking a skilled Clinical Trial Manager, Site Start-Up to support their rapidly expanding clinical programs. Reporting to the Director of Clinical...


  • Waltham, United States Apellis Pharmaceuticals Full time

    Senior Clinical Trial Managerat ApellisWaltham, Massachusetts, United StatesPosition Summary:The Senior Clinical Trial Manager is responsible for oversight and the overall management, planning, implementation, and execution of clinical trial(s) in a fast-paced environment with minimal oversight from the Associate Director/Director, Clinical Operations. The...


  • Waltham, United States Welsh & Associates Full time

    The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office...


  • Waltham, Massachusetts, United States Abacus Search Staffing Full time

    The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid...


  • Waltham, United States Professional Outlook Full time

    The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid...


  • Waltham, United States Miltenyi Biotec Full time

    Description Your Tasks: The Senior Clinical Trial Manager drives the clinical trial execution activities for assigned clinical trials, and ensures trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines. Essential Duties and Responsibilities: Provide input to the clinical...


  • Waltham, United States Miltenyi Biotec Full time

    Your Tasks: The Senior Clinical Trial Manager drives the clinical trial execution activities for assigned clinical trials, and ensures trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines. Essential Duties and Responsibilities: Provide input to the clinical development plan...


  • Waltham, Massachusetts, United States Dana-Farber Cancer Institute Full time

    Job Summary:The Senior Clinical Research Coordinator works within the Dana-Farber Regional Campus clinical research program and supports the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI disease programs.Key Responsibilities:Primary data collection,...


  • Waltham, Massachusetts, United States Tbwa ChiatDay Inc Full time

    About the RoleWe are seeking an experienced Clinical Operations professional to join our team at Affinia Therapeutics. As the Head of Clinical Operations, you will be responsible for driving the U.S. and global clinical operations strategy and implementation.Main Responsibilities:Developing clinical operations strategies for cardiac gene therapy agents in...


  • Waltham, Massachusetts, United States Clinical Dynamix Full time

    Clinical Data Management DirectorThe Associate Director, Clinical Data Management is a key role at Clinical Dynamix, responsible for overseeing the start-up and execution of multiple complex trials with CROs. This individual will define and lead the clinical data management strategy for the organization, ensuring data quality and timeliness align with...


  • Waltham, United States Viridian Therapeutics, Inc. Full time

    At Viridian Therapeutics, 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,...


  • Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Job Description Job Description Job Title: Clinical Trial Associate Location: Metro Boston preferred, hybrid working model Location: Waltham, MARemote Flexibility: 2-3 days/week on-siteContract Term: 6 months to start; could extend or go permExperience required:Preference is experience at CRO or small biotech for at least 1-2 years with exposure to...


  • Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Job Description Job Description Position Overview:The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing...


  • Waltham, 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...


  • Waltham, Massachusetts, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex...