Senior Clinical Operations Specialist (Multiple Sclerosis)

Neuraxpharm is the leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions.
The company has more than 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, and globally via partners in more than 60 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.
Neuraxpharm is searching a vacancy based in Barcelona, Sant Joan Despi:
Senior Clinical Operations Specialist (Multiple Sclerosis)
Work closely with the Clinical Team and the selected CROs to ensure successful conduct of the clinical trials sponsored by Neuraxpharm, following ICH-GCP guidelines, all applicable regulatory requirements, and all internal SOPs.
This role is responsible for the oversight of clinical trial activities, logistical aspects, vendor coordination, and able to contribute to budget management of assigned clinical trials and non-interventional/RWE studies executed by CROs or other parties on behalf of Neuraxpharm.
Being His/Her Major Accountabilities

• Responsible for effective and smooth workflow between study participants (i.e., CROs clinical team, third-party vendors, and monitoring partners).
• Identify, select and hire CROs, third vendors, registry providers, and/or public sites to perform clinical studies.
• Coordinate the regulatory request of pertinent authorizations to the applicable Health Authorities to perform clinical studies, as well as the corresponding certificates and associated documentation.
• Follow-up with vendors and monitoring partners on day-to-day operations (recruitment reports, meetings, delivery of study kits …)
• Meeting set-up, minutes, running reports from systems, draft study documentation.
• Set-up and coordination of third-party vendors (i.e., central lab, investigators’ meeting organization) and monitoring partner, ensuring all information, documents and material is in place for study start.
• Responsible for evaluation of investigators fees and participant institutions agreements, as well as its associated negotiation ensuring accurate planning, tracking and reporting of study budget.
• Responsible for the review and maintenance of key study documents and their filing as appropriate in Trial Master File (TMF).
• Support Pharmaceutical Development Unit in keeping overview of drug availability at site level in collaboration with CRO and drug supply management partners.
• Follow up and coordinate with CROs the activities related with study start-up, regulatory approvals, recruitment and close-out as required.
  

We Require

• 5 years operational experience of clinical study execution / oversight in a pharmaceutical company or CROs AND/OR
• 7 years developing tasks as a senior Clinical Research Associate with complete autonomy.
• Significant clinical research experience in therapeutic advanced clinical trials (Ph2b and Ph3) and non-interventional studies, including Ph IV post-authorization studies, RWE, and registries.
• Previous CNS therapeutic area experience is a must, ideally in Multiple Sclerosis and Schizophrenia.
• Strong technical and organizational skills, detailed oriented, thorough knowledge of GCP, Clinical Operations processes, and SOPs from the project management point of view.
• Clinical Development experience in pilot and pivotal trials formulations, long acting injectables, inhaled formulations, patches, etc.
• Medical writing experience for the preparation and review of clinical regulatory documents (CSP, CSR, ICF, IBs, etc.) and for the preparation of study-derived congress communications, abstracts, and manuscripts.
• Statistics applied to Clinical Research
• Knowledge on GCPs and ICH guidelines
  

We Offer

• Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
• Economic conditions will be according to the experience and skills provided.
• A motivated and committed environment based on a diverse and inclusive culture.
• A specialized team focused on our core activity: Improving our patients’ lives.
  

www.neuraxpharm.com