Regulatory & Start up Manager (Home-Based) - MedTech at IQVIA in Cleveland, OH

Responsibilities:

• Responsible for the set-up and execution of regulatory related tasks within the designated clinical projects in compliance with the regulatory requirements throughout involved countries with reference to the relevant legislations, applicable guidelines and IQVIA MedTech SOPs.
• Acts as an intermediary between the different parties involved, which may include a Regulatory Authority, Ethics/Review Committee, study investigators, third party vendors (e.g. consultants and translation agencies) and the client.
• Final responsible for performance of correct and complete submissions to IRB or any other applicable body involved in the clinical study.
• Reviews IRB submission documents (e.g. application form, ICF, …)
• Pro-actively identifies regulatory related issues and set-up strategies to handle this efficiently.
• Follows-up on the development and collection of the required regulatory documentation.
• Guides and supports members of the project team (specifically the Regulatory & Start-up Specialist) to ensure adherence with regulatory requirements, timelines and budget.
• Acts as a contact person for all regulatory related aspects within the organization.
• Coordinates and cooperates with third party vendors if applicable (e.g., consultants, translation agencies etc.).
• Evaluates and formulates recommendations or improvements to company systems & processes to ensure clinical study regulatory issues are identified and resolved.
• Writes and/or provides input to department specific SOPs and Working Practices.
• Controls the regulatory budget per project in close cooperation with the client and the Clinical Project Manager.
• Assures adherence to ICH-GCP, compliance with IQVIA MedTech safety SOPs, study procedures and regulatory requirements.
• Attends study-related, company, departmental, and external meetings, as required.
• Provides ongoing coaching and development of training materials to new staff or where needed.
• Performs other related duties as assigned or requested.

Knowledge, skills and abilities:

• Higher educational degree (BSc, MSc) in a medical or science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.
• At least five years of clinical research experience with two years in a medical device/drug clinical submissions or study start-up related function.
• Equivalent combination of relevant education and experience.
• In depth knowledge of clinical research process, medical terminology, ICH-GCP, GDPR, ISO 14155 and applicable FDA/EU regulations and guidelines.
• Excellent written and verbal communication skills.
• Fluent in English, by preference in more languages.
• Excellent attention to detail, planning and organizational skills.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Ability to work independently, pro-actively, problem-solving, prioritize effectively and work in a matrix team environment required.
• Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
• Advanced computer literacy and skills in working with Microsoft Office (Word, Excel, PowerPoint) required