Clinical Operations Manager
SallyQ AB / Kemiingenjörsjobb / Solna
2024-11-14
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hela Sverige Curacell is an innovative startup company focused on developing advanced therapies in the field of regenerative medicine and tissue engineering, with a particular focus on cancer immunotherapy. The company is pioneering Tumor Infiltrating Lymphocyte (TIL) therapy, a novel approach for treating cancer using the patient's own immune cells. Curacell is expanding its clinical operations and is now looking for a Clinical Operations Manager to lead the execution of clinical trials and build strong partnerships for future clinical studies.
The position:
As Clinical Operations Manager, you will oversee all aspects of clinical trial management, from design to close-out, ensuring adherence to timelines, budgets, and regulatory standards. You will collaborate closely with cross-functional teams and external partners to drive the clinical development of Curacell's TIL therapy and support its transition into clinical phases.
Key Responsibilities:
Lead the planning, execution, and close-out of clinical trials, ensuring compliance with regulatory requirements (GxP, ICH-GCP).
Manage cross-functional teams, including CROs, clinical sites, and vendors, to ensure timely and efficient trial delivery.
Build and maintain a strong network of clinical sites and clinicians to support upcoming studies and R&D collaborations.
Identify risks and opportunities, and implement mitigation strategies.
Collaborate with senior leadership to design clinical programs and drive the overall clinical development strategy.
Ensure high-quality clinical trial documentation and support regulatory filings, inspections, and submissions.
Key Qualifications:
Education: Bachelor's degree in Life Sciences, Medical Sciences, or related field, or equivalent work experience.
Experience:Minimum of five (5) years in clinical operations and a total of 10 years of combined work or research experience in Life Sciences. Experience in ATMP is highly advantageous.
Regulatory Knowledge: Strong understanding of GCP and regulatory requirements.
Technical Skills: Proficiency in Microsoft Office and basic computer tools.
Communication: Excellent oral and written communication skills in English. Swedish skills ishighly advantageous.
Why Join Us:At Curacell, you will be part of a fast-paced, innovative environment focused on developing life-changing therapies. This is an exciting opportunity to be part of a growth journey in the field of ATMP.
Application:
In this recruitment Curacell is collaborating with SallyQ. If you are interested in the position and want further information, contact Senior Recruitment Consultant Ellinor Crafoord 079-3554257 or
ellinor.crafoord@sallyq.seApplication deadline: December1st 2024
About Curacell:
Curacell is based in Stockholm, Sweden.Curacell is a European cell therapy company developing a Tumor Infiltrating Lymphocytes (TIL) based product for the treatment of cancer. Curacell has a history of decades-long TIL research in Sweden and leading clinical expertise in Germany. With this knowledge and further growth Curacell aim at delivering durable TIL treatments to patients with solid tumor cancers.
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Så ansöker du Sista dag att ansöka är 2025-05-03
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Arbetsgivare SallyQ AB (org.nr 559463-4577)
Jobbnummer 9011582