Senior Project Manager R&D

The Senior Project Manager R&D maintains a good level of knowledge of the business and the regulatory evolutions in the field, and looks for continuous improvement of the processes implementing needed business requirements for the client.

Job Description

• Define the Clinical Trial Submission strategy within R&D and manage the planning, coordination and/or preparation, dispatch and follow-up on the initial clinical trial application file, Q&A’s, amendments, end of trial notification and summary of clinical trial report in order to ensure a timely submission to appropriate authorities such as Competent Authorities.
• Maintain GRA TMF compliance.
• Upload and maintain the third country form (related to articles 41 & 46) via the EMA gateway.
• Flag operational issues and propose solutions in a timely manner.
• Support the Regulatory and Clinical LOCs for their submission to their authority by providing help and guideline on procedural and administrative matters (including Direct Filling to Agency process).
• Prepare/coordinate MSR when needed.
• Ensure training of new employees and sharing best practices across GRA business and to external stakeholders.

Profile

• More than 5 years of experience in a similar position.
• Fluent in English.
• Project management-oriented, solution-oriented.

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.