Study Start-Up Specialist page is loaded

Study Start-Up Specialist

Apply locations Braine L'Alleud - BE Utrecht - NL time type Full time posted on Posted 22 Days Ago job requisition id R1577409

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us .

Outline of Key responsibilities:

•Responsible for activities related to Clinical Trial Study Start Up and ongoing study document management across Northern Europe Cluster (UK, Ireland, Belgium, Netherlands).

• Manage multiple country, study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.

• Plan and develop strategy for start-up activities to ensure successful recruitment and delivery to trial milestones.

• Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.

• Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).

• Collaborate with other internal roles in country feasibility and site selection.

• Collaborate directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines.

• Prepare protocol-specific country Informed Consent Form (ICF).

• Customise site ICFs.

• Review and approval of Clinical Trial Package (CTP) documentation.

• Ensure that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.

• Support the collection and distribution of documents from / to sites including obtaining insurance certificates.

Required experience:

3 or more years of industry related experience including handling of trial start-up activities

Degree Requirements:

Bachelor's degree required preferably within life sciences or equivalent.

Key competency requirement:

Thorough understanding of GCP, ICH Guidelines and Country regulatory environment

• In depth knowledge and understanding of clinical research processes, regulations and methodology

• Demonstrated organizational and planning skills and independent decision-making ability

• Strong organization and time management skills and ability to effectively manage multiple competing priorities

• Ability of critical thinking and risk analysis.

Languages requirement:

Good verbal and written communication skills, both in English and local language such as Dutch/French.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

W e’re creatinginnovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

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