Clinical Trial Manager
3 weeks ago
About 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 from larvae to adults, ascidians re-engineer their transcriptome through RNA editing via trans-splicing and alternative splicing.In our Brighton/Boston labs, RNA biology meets today's cutting-edge genomics, computational biology, and deep-sequencing technologies to create a new class of medicines that address the underlying causes of disease. We welcome you to come join our vibrant team and help us lead the way into a new gene therapy era.Summary:The Clinical Trial Manager will be responsible for the oversight, coordination, and execution of gene therapy clinical trials in support of Ascidian clinical programs in all phases of development. This is a tactical position and involves protocol execution at the site and project level through established vendor oversight and escalation pathways.Job responsibilities:Works closely with the Associate Director and will be responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.Manage all operational aspects of assigned clinical trial(s)Support the selection of vendors/CROs and provide effective ongoing management to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol.Independently manages assigned clinical studies.Monitor and track clinical trial progress and provide status updates to stakeholders and at project team meetings to senior management as needed.Oversee all aspects of data cleaning and facilitate data locks, including oversight of clinical sites, CRO, vendors, and collaboration with data management/statistics teams.Proactively identify potential issues/risks and recommend/implement solutions.Coordinates and/or participates in the development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study-related documents.Oversees and works directly with CROs, vendors, and all other partners. Establishes relationships with investigators, study coordinators, site personnel, and other external key stakeholders.Accountable for developing and managing study budgets and financial reporting, including month-end and quarterly reporting, financial reconciliation, accruals, and re-forecasting, with Clinical, Finance, and Project ManagementWorks with the Patient Recruitment/ Advocacy department and is responsible for the oversight of the recruitment strategy, enrollment projections, and meeting established targets.Presents at clinical team meetings and other forums on study progress.May travel to site visits, co-monitoring visits, Investigator Meetings, and conferences as applicable.Job qualifications and requirements:Thorough understanding of FDA, ICH, and GCP guidelinesProven track record showing clear proficiency in clinical trial management skillsProven complex problem-solving skills collaboratively and independentlySolid vendor management experience, e.g., CRO, laboratory, and /or clinical supply logisticsBroad understanding of clinical operations related to the pharmaceutical drug development processAbility to effectively interface with personnel at clinical sitesAbility to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documentsExcellent interpersonal, verbal, and written communication skillsComfortable in a fast-paced small company environment and able to adjust workload based upon changing prioritiesEducation and experience:BA, BS in biological science, or degrees in nursing, pharmacy, medical technology, or other allied healthcareMinimum of 5 years of clinical trial management experience, at least 3 of which are as a Clinical Trial Manager for clinical development studies at a pharmaceutical/biotech organization or a combination of CRO and pharmaceutical/biotechExperience with Phase I - III clinical trialsProficiency with computer programs such as Google Suite & Microsoft Office Benefits:We provide a vibrant startup environment where every employee contributes to our culture and science. We offer a generous total rewards plan that includes competitive compensation, stock options, and benefits. Our benefits include a top-tier health and wellness plan, commuter reimbursement or paid monthly parking, tuition or loan reimbursement, career development opportunities and so much more.A final note - we highly encourage you to apply for our position, even if you are not sure you meet all the requirements. Everyone has unique talents, and at Ascidian, we look not only at your experience but your potential. We know that the best teams consist of diverse backgrounds, so please apply
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Senior Clinical Trials Manager
4 weeks ago
Boston, United States Clinical Dynamix Full timeThe 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 in their Waltham, MA headquarters. Their office-based employees follow a hybrid...
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Boston, United States Meet Full timeAre 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 a prominent biopharmaceutical company dedicated to advancing novel therapies...
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Clinical Trial Manager
1 day ago
Boston, United States Work In Biotech Full timeAbout 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 from larvae to adults, ascidians re-engineer their transcriptome through RNA editing via...
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Clinical Trial Manager
2 weeks ago
Boston, United States Ascidian Therapeutics Full timeAbout 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 from larvae to adults, ascidians re-engineer their transcriptome through RNA editing via...
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Boston, United States Meet Full timeAre 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 a prominent biopharmaceutical company dedicated to advancing novel therapies...
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Boston, United States Meet Full timeAre 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 a prominent biopharmaceutical company dedicated to advancing novel therapies...
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Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Clinical Trial Manager
3 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Boston, United States Imbria Pharmaceuticals Full timeCompany Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Boston, United States Imbria Pharmaceuticals Full timeCompany Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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1 month ago
Boston, MA, United States Joulé Full timeTitle: Clinical Trial Lead Location: Boston, MA. Start Date: ASAP! Duration: Contract-to-Hire Hours: Mon-Fri; 8:30am-5pm Overview Our client is a hospital which is internationally-known referral center for the most complex cases in nearly all areas of medicine. Some of their specialty areas include: Cancer, Heart, and Vascular. Requirements: BS degree...
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