- BS/BA in life sciences preferred
- A minimum of 5 years of direct experience in clinical trial execution
- Excellent communication (verbal and written), organizational and problem-solving skills
- Prior experience developing and managing clinical trial budgets preferred
- Experience managing external contract research relationships.
- Prior clinical monitoring experience preferred
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Clinical Trial Manager
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Clinical Trial Manager
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Clinical Trial Manager
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Fusion Pharmaceuticals LLC Boston, United StatesFusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...
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Clinical Trial Manager
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Ascidian Therapeutics Boston, United StatesAbout us: · Ascidian is redefining the treatment of disease by rewriting RNA. · Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. We were inspired by ocean creatures, called Ascidians, who are primordial ancestors of vertebrates. To grow fro ...
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Clinical Trial Manager
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Clinical Trial Manager
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Clinical Trials Manager
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Senior Clinical Trial Manager
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Third Rock Ventures Boston, United StatesAs a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximall ...
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Senior Clinical Trial Manager
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Sr. Clinical Trial Manager
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ProClinical Boston, United StatesProclinical is seeking a dedicated Senior Clinical Trial Manager (CTM) to join our global Clinical Operations Department. The successful candidate will play a crucial role in managing and executing clinical trials, ensuring compliance with regulations, maintaining timelines, and ...
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Senior Clinical Trials Manager
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Clinical Dynamix Boston, United StatesThe Senior Clinical Trials Manager is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM level reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. · This role is based i ...
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Senior Clinical Trials Manager
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Associate Director Clinical Trial Management
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Senior Manager, Clinical Trial Lead
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Olema Oncology Boston, United StatesWho We Are >>> Why You Should Work With Us · Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprieta ...
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Clinical Trial Project Manager USA
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Clinglobal Group Boston, United StatesJob Description · Job Description Salary: Between $81,000 and $172,000 per annum · Clinical Trial Project Manager - United States of America · Clinglobal is part of a group of Animal Health Contract Research Organisations servicing the global animal health industry. · We're act ...
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Meet Boston, United StatesAre you an experienced Clinical Operations professional looking to advance your career in a dynamic and innovative environment? Do you thrive in a fast-paced setting and excel at managing clinical trials from start to finish? If so, we have an exciting opportunity for you to join ...
Contract Clinical Trials Manager - Boston, United States - Clinical Dynamix
Description
Clinical Phase Publicly Traded Biopharmaceutical company focusing in pulmonary delivered therapiesJob Summary: CTM work from home 3 days a week and in-office in Tuesdays and Thursday (flexible hours) 40 hour/week Contract to begin with option to convert to perm/Full time
The Clinical Trial Manager (CTM) will be responsible for managing a broader range of activities on large multi-center studies as well as independent management of clinical trials of easy to moderate complexity. The CTM will assume many critical activities to support the Clinical Operations team to execute on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. This is a full remote contract opportunity.
Major Responsibilities:
•Clinical study team member: works closely with the Director, Clinical Operations and is responsible for day to day operational management of clinical trials.
•Manages all clinical aspects of study, including: managing study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel, executes and attends/manages study specific meetings (eg Study Team Meetings, investigator teleconferences, safety review meetings, etc) as applicable, participates in site monitoring visits as appropriate
•Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs; ensure audit-ready conditions of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate
•Prepares and reviews site study documents (eg site-specific informed consent, study tools/worksheets, investigator contracts, and site payments)
•Develops relationships with investigators and site staff
•Works with study team to design clinical trial protocol and assists in developing/managing ongoing data review to ensure detection of data trends and to ensure study objectives are met; prepares study-related documentation; supports the creation of the ICF templates, CRFs, etc
•Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals.
•Assists in development and management of study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budgets
•Manages clinical monitoring activities including approval of visit report templates, monitoring plans, ensuring compliance with ICH/GCP and applicable regulations.
Qualifications (Education, Experience, Knowledge and Skills):
