- 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 Management
- Works 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.
- Thorough understanding of FDA, ICH, and GCP guidelines
- Proven track record showing clear proficiency in clinical trial management skills
- Proven complex problem-solving skills collaboratively and independently
- Solid vendor management experience, e.g., CRO, laboratory, and /or clinical supply logistics
- Broad understanding of clinical operations related to the pharmaceutical drug development process
- Ability to effectively interface with personnel at clinical sites
- Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Excellent interpersonal, verbal, and written communication skills
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
- BA, BS in biological science, or degrees in nursing, pharmacy, medical technology, or other allied healthcare
- Minimum 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/biotech
- Experience with Phase I - III clinical trials
- Proficiency with computer programs such as Google Suite & Microsoft Office
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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 ...
Clinical Trial Manager - Boston, United States - Ascidian Therapeutics
3 weeks ago
Description
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:
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
