Lead Study Start-up Specialist – Belgium (Home-based)

Lead Study Start-up Specialist - Belgium (Home-based)

Our client is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Their clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 25,000 professionals worldwide, our client applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

Basic Purpose and Objective:

Manages the preparation, review and coordination of Country Submissions in line with the global submission strategy.

Essential Functions:

Prepares, reviews and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) aligned with global submission strategy.

• Provides local regulatory strategy advice (MoH & EC) to internal clients.
• Provides project-specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed promptly.
• Ensures guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed promptly.
• Acts as a key contact at the country level for all submission-related activities.
• Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings.
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of the submission process for sites and studies is aligned to the critical path for site activation.
• Achieves our client's target cycle times for site activations.
• Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• Develops country-specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Assists in identifying and recognizing local out-of-scope activities in a contract promptly and advises relevant functions.
• Supports the coordination of feasibility activities, as required, by agreed timelines.
• Ensures that trial status information relating to SIA activities is accurately maintained in the database and is always current.
• Oversees country study files and ensures that they meet WPDs or client SOP's.
• Directs/mentors other SIA individuals assigned to support projects of responsibility, as appropriate.
• Prepares and maintains country master document templates and other regulatory intelligence systems, as may be required and assigned.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic/vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Knowledge, Skills and Abilities:

• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Solid negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Good judgement and decision-making skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, with minimal supervision, as required
• Ability to mentor fellow SIA team members in a positive and effective manner
• Excellent team player with team-building skills
• Good organizational and planning skills
• Excellent knowledge of all applicable regional/national country regulatory guidelines and EC regulations

If you would like to find out more, reach out to me at

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.