Global Submission Management – Clinical Trials (GSM-CT) Specialist - Bristol-Myers Squibb - Braine-l'Alleud

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Department Title and Description

Global Submission Management

Planning, coordination, preparation and tracking of the documents required for the clinical trial application to Competent Authorities (CAs) and/or Ethics Committees (ECs) to start and execute a BMS sponsored Interventional Phase I - IV studies in participating countries, in compliance with the regulatory requirements and BMS processes.

In scope - all countries involved in CTs except the US

Key Responsibilities and Major Duties

• Responsible for the planning and the preparation of the clinical trial applications (CTAp) for programs conducted mainly in the EU with focus on Substantial amendments, coordinating updates at program level. The specialist will gain expertise to progressively be assigned to initial applications of increasing complexity.

1. Assist GSM - CT with the preparation, distribution and tracking of the core Clinical Trial Application dossier and subsequent amendments (IB/CMC at program level + revised protocols).
2. Assist GSM - CT with Verity (HA submission and approval Tracking system) by creating events/activities/registrations/running reports etc
3. Ensure consistency of the Clinical Trial application across projects, studies and countries
4. Actively participate in Program level CTAp Tracking Meetings, led by senior role, in preparation of the CTAp dossier, ensuring timelines and dossier quality are managed according to expectations
5. Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.
6. Escalate to study teams and GCT-SU senior roles observed trends and issues that may impact timely and successful study approval and execution
7. Expected to be able to coordinate updates within a Program.
8. Support continuous improvement and compliance initiatives
9. Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates
10.Support GSM - CT in creation of End of Trial and tracking, as well as distribution of CSRs to Country Applicants.
11.Contributes to other requirements as appropriate to allow proper functioning of the GSM - CT.

• Support implementation of the EU CT REG Portal.
• Contribute to the Country Requirements Repository by collecting and sharing additional country requirements.
• Ensure timely support for Investigator Sponsor Research Trials (ISRs) at EU level. Create cross Reference Letters and when not possible coordinate submission of CMC documentation with local Regulatory.

Competencies - knowledge, skills, abilities, other

• Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing, a Master's degree is preferable
• 2 years of clinically related or relevant experience:
• knowledge of the pharmaceutical industry (thorough understanding of ICH-GCP guidelines) and of the pre-clinical, clinical, regulatory and commercial components, the drug development process and the impact of regulations worldwide.
• knowledge of general clinical research including project management issues, important milestones and strategies to ensure timelines are met.
• experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry. EU process and package content is an asset.
• experience in effective implementation of clinical plans/documents and document preparation.
• previous experience working in an international team environment within a matrix organization Fluent in English (written and spoken)
• Proficient use of other applications and software (Excel, Powerpoint, eConferencing, etc) to fully support processes.
• Demonstrates flexibility to work simultaneously on projects of different therapeutic areas and different countries. Communicates effectively using excellent verbal and written skills with both internal and external key stakeholders; coordinates information and document flow to and from both internal and external customers.
• Works well in a team environment, collaborates effectively with internal groups and demonstrates a "can do" approach. Utilizes effective problem-solving approaches and independently follow-up and resolves outstanding issues, within deadlines to achieve key deliverables.
• Exhibits flexibility and willingness to develop new skills by being receptive to new systems and processes. Seeks to identify and implement best practices.
• Analytical and detailed-orientated skills in tracking and analyzing numerical and other data

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.