We have other current jobs related to this field that you can find below
-
Clinical Trial Manager
1 month ago
Boston, United States Inozyme Pharma Full timeWe are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational...
-
Clinical Trial Manager
1 month ago
Boston, Massachusetts, United States Inozyme Pharma Full timeWe are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational...
-
Clinical Trials Manager
6 days ago
Boston, Massachusetts, United States Mass General Brigham Full timeGENERAL SUMMARY/OVERVIEW STATEMENT: The Brain Modulation Lab within the Department of Neurosurgery at Mass General Brigham is in search of a dedicated and detail-oriented Clinical Trials Manager. This role is essential for overseeing clinical studies and research initiatives. The successful candidate will handle all aspects of data and sample acquisition for...
-
Clinical Trial Manager
3 weeks ago
Boston, United States Inozyme Pharma Full timePosition Overview: We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate...
-
Clinical Trial Manager
3 weeks ago
Boston, Massachusetts, United States Inozyme Pharma Full timePosition Overview:We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate...
-
Clinical Trial Associate
2 weeks ago
Boston, United States Bicara Therapeutics Full timeAbout Bicara Therapeutics: Bicara Therapeutics is a biopharmaceutical company focused on developing innovative therapies to address unmet medical needs. Our mission is to bring groundbreaking treatments to patients with serious conditions by leveraging cutting-edge science and fostering a collaborative, dynamic work environment.Job Summary: The Clinical...
-
Clinical Trial Associate
2 weeks ago
Boston, United States Bicara Therapeutics Full timeAbout Bicara Therapeutics: Bicara Therapeutics is a biopharmaceutical company focused on developing innovative therapies to address unmet medical needs. Our mission is to bring groundbreaking treatments to patients with serious conditions by leveraging cutting-edge science and fostering a collaborative, dynamic work environment.Job Summary: The Clinical...
-
Clinical Trial Manager
2 months ago
Boston, United States Cpl Full timeManager, Trial Operations (or Senior Manager)Must live in one of these locations: - NJ, NY, DE, CA, MA, FL, D.C, DE, OR, CO8 years of experience as a CTM is required.If you do not meet these requirements, you will be instantly rejected. The successful candidate will work hands-on on several trials acting as a study lead and a manager. The successful...
-
Sr. Clinical Trial Manager
2 months ago
Boston, United States RBW Consulting Full timeJob Title: Senior Clinical Trial ManagerLocation: Boston, MAOur client are a dynamic and innovative biotechnology company at the forefront of cellular therapy. Our mission is to develop cutting-edge treatments that improve patients' lives. Based in the vibrant biotech hub of Boston, we are a small but growing team dedicated to pioneering new therapies and...
-
Sr. Clinical Trial Manager
2 months ago
Boston, United States RBW Consulting Full timeJob Title: Senior Clinical Trial ManagerLocation: Boston, MAOur client are a dynamic and innovative biotechnology company at the forefront of cellular therapy. Our mission is to develop cutting-edge treatments that improve patients' lives. Based in the vibrant biotech hub of Boston, we are a small but growing team dedicated to pioneering new therapies and...
-
Senior Clinical Trial Manager
2 weeks ago
Boston, United States Bicara Therapeutics Full timeRole OverviewThe Senior Clinical Trial Manager works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial...
-
Associate Director, Clinical Data Management
3 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE 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
3 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE 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...
-
Sr./Clinical Trial Manager
2 weeks ago
Boston, Massachusetts, United States Actalent Full timeJob Title: Clinical Trial Manager Job Description We are seeking a seasoned Clinical Trial Manager with 4-7 years of experience in clinical trial management at a CRO or Pharma/biotech company. Candidates with experience in small companies and oncology are highly preferred. The role involves managing and overseeing multiple CROs and ensuring good clinical...
-
Sr./Clinical Trial Manager
2 weeks ago
Boston, United States Actalent Full timeJob Title: Clinical Trial Manager Job Description We are seeking a seasoned Clinical Trial Manager with 4-7 years of experience in clinical trial management at a CRO or Pharma/biotech company. Candidates with experience in small companies and oncology are highly preferred. The role involves managing and overseeing multiple CROs and ensuring good clinical...
-
Boston, United States Bicara Therapeutics Full timeRole OverviewThe AD, Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial...
-
Boston, United States Bicara Therapeutics Full timeRole OverviewThe AD, Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial...
-
Senior Clinical Trial Manager
2 months ago
Boston, United States ARTO Full time(Candidate must be located in Massachusetts)ARTO is currently working with a leading oncology biotech company dedicated to developing innovative therapies to combat cancer. With significant funding and a robust pipeline of promising drug candidates, we are at the forefront of cancer research and treatment. Our mission is to improve the lives of patients...
-
Senior Clinical Trial Manager
2 months ago
Boston, United States ARTO Full time(Candidate must be located in Massachusetts)ARTO is currently working with a leading oncology biotech company dedicated to developing innovative therapies to combat cancer. With significant funding and a robust pipeline of promising drug candidates, we are at the forefront of cancer research and treatment. Our mission is to improve the lives of patients...
-
Clinical Trial Associate
1 month ago
Boston, United States Pharmaceutical Research Associates, Inc Full timeOverview As a Clinical Trial Associate, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What you will be doing: Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day–to–day operational activities of assigned trials...
Clinical Trial Manager, Start Up
2 months ago
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. Remote work is allowed, and the frequency is at the discretion of management.
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
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast paced-environment and to handle multiple tasks
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 10%
- 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
