Senior Clinical
Trial Manager
About us
Everyone should have access to innovative therapies that represent the promise of lasting cures. Theolytics aims to develop category changing curative cancer therapies in the form of best-in-class oncolytic viruses. The company will be evolving over the next 12-months to drive the development of a pipeline of pre-clinical candidates into the clinic.
Theolytics is committed to creating, inspiring and protecting a culture of inclusivity and diversity in everything we do. We bring our authentic selves to work, and strive to find and support the best person for any given role within our team. Our recruitment leads with capability, values and performance.
Opportunity
We are looking for a Senior Clinical Trial Manager, to join our team. This position represents an excellent opportunity for someone looking to drive the development of category changing cancer therapies. The successful applicant will be working in a fast-paced environment, to deliver strategic clinical development goals, and advance oncolytic virus products for patients. We are looking for someone who is a self-starter, has excellent communication skills, can drive results through coordinating effectively with a diverse, international set of stakeholders, and is happy to jump in when
required in what will be an exciting work environment.
Key responsibilities
Lead clinical operations activities within Theolytics for a trial/ asset, coordinating internal and external stakeholders to ensure that the company’s clinical trials are effectively executed to timelines, and on budget. This will include:
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Oversight and management of CRO and Specialty-lab vendors.
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Review of site contracts and budget negotiations.
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Reviewing and providing expert clinical operations input into clinical documentation.
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Management of clinical trial site validation, preparation and set-up.
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Management of clinical trial logistics including clinical samples, and the Investigational Medicinal Product.
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Input into clinical biomarker strategy, and coordination of specialty vendors to enable successful
execution. -
Management of clinical trial progress to ensure:
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ongoing compliance of all stakeholders involved in accordance with ethical and
regulatory standards including ICH and GCP guidelines. -
completeness, quality and integrity of documentation and data collection.
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adherence with project timelines, including the timely review and roll-out of any
protocol or vendor changes required -
activities and invoicing is in line with budget and service agreements.
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that the Senior Leadership team is appraised and up to date on clinical trial progress.
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Contribute to forward-looking strategy for clinical trial operations in alignment with company goals and objectives.
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Contribute to build-out and development of Theolytics clinical operations function
This role will involve
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Developing solutions to accelerate study start up and recruitment.
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Traveling to clinical sites when necessary (anticipated to be UK, and internationally)
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Cultivating strong relationships with study site personnel including investigators, trial nurses, CROs, vendors etc.
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Planning for, and mitigating clinical trial-associated risks where possible.
We’re looking for someone that has
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A degree in life sciences or a related field.
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Experience in clinical trial operations ideally in a biotech environment.
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Experience in oncology/immune-oncology and with GMO products would be beneficial.
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Strong knowledge of clinical trial design and execution, regulatory requirements and quality standards.
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Excellent leadership, organisation and project management skills.
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Strong communication and interpersonal skills to effectively communicate with internal and external stakeholders.
