Study Start Up Regional Lead FSP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Our dedicated teams combine and deliver startup activities for the clinical trials collaborating to improve processes cycle and flexibility. We partner with our sites businesses and colleagues around the world to decrease startup timelines and exceed expectations.

The Study Start Up (SSU) Regional Lead- FSP is responsible for managing effective delivery of site activation within their assigned region(s). This role involves overseeing site activation according to timelines and quality standards coordinating with SSU Specialists and managing technical and operational aspects.

• Collaborate with team members to ensure effective site activation within assigned studies.
• Coordinate SSU specialists across regions.
• Ensure sites within their specific region are on track with the critical path site activation plan.
• Serve as an escalation point for issues identified by SSU specialists including regulatory and vendor setup issues.
• Facilitate knowledge transfer across countries within regions.
• Work with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.
• Oversee site activation according to timelines and quality standards within their specific region.
• Assist with information flow between key stakeholders involved in site activation.
• Oversee EC submission strategy and required documents (e.g. patient material insurance certificates).
• Provide quality checks for EC submission packages for both central and local ECs.
• Manage technical and operational aspects including feasibility site selection contracts coordination and EC/RA submissions.
• Ensure operational readiness for site activation in collaboration with CML (e.g. site binders ancillary supplies lab kits training system access).
• Monitor regional study status identify risks and provide metrics to Study Start-up (SSU) Oversight Lead.
• Maintain metrics and tracking tools for regional startup activity.
• Perform risk identification and contingency planning participate in risk escalation meetings as required and collaborate with study team to address issues and implement solutions for countries and sites in region.
• Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.
• Provide performance feedback to People Manager and support staff learning opportunities.
• Utilize problem-solving techniques in a changing environment.
• Prepare for and participate in country level meetings.
• Oversee and manage the clinical trial insurance local policy country set-up for region.
• Oversee and manage amendment implementation as needed.

Location/Division Specific Information

This is a home-based position and preferably based in Melbourne Sydney Brisbane Adelaide or Perth.

Skills and Abilities:

• Effective collaboration with cross-functional teams.
• Knowledge of key principles of cross-functional project management.
• Strong organizational and multitasking skills.
• Attention to detail.
• Ability to identify and mitigate risks related to contractual deliverables.
• Cross-cultural awareness and adaptability.
• Comprehensive understanding of clinical research and development including medical and therapeutic areas phases and terminology.
• Ability to lead liaise and coordinate cross-functional project teams.
• Knowledge of clinical development guidelines and directives.

Education and Experience:

• Bachelors degree/previous experience that provides the knowledge skills and abilities to perform the job comparable to 5 years

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Australia citizenship or permanent residency required

Benefits