Clinical Trail Liaison (Contract)

Title: Clinical Trial Liaison (CTL)

Reports to: Senior Director, Head of EU Clinical Operations

Location: Remote

Position Overview:

The Clinical Trial Liaison (CTL) supports Global Development clinical study execution as the local field-based representative for Prothena in one or more countries/regions supporting clinical development programs. The CTL interacts with investigator sites and other parties related to clinical trial execution.

The CTL provides regional and country specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In collaboration with the study team, the CTL both identifies and helps facilitate resolution of investigator site issues.

Serving as a value-added resource, the CTL will educate, analyze, and resolve issues with clinical research sites and investigators. Acting as a liaison between Prothena, the clinical study sites and the CRO, the CTL will be responsible for conducting outreach to clinical investigators and site staff to implement and coordinate clinical trial recruitment efforts with the goal of achieving enrollment timelines.

Responsibilities:

· Provides country/regional operational insight into site feasibility and selection

· Accountable for site-specific patient recruitment and retention strategy

· Engages site staff and investigators in discussions to understand and report challenges in subject enrollment and retention and offer potential solutions

· Assists in the implementation and oversee the execution of site-specific patient recruitment tactics

· Proactively communicates site plans, findings, and insights to relevant Study Management Team (SMT) members

· Communicates investigator/study coordinator inquiries requiring follow-up to designated contacts within Prothena

· Participates in Clinical Study Team Meetings providing input to study teams on pre-screening activities and operational issues based on site visits and contacts

· Attends and presents at investigator meetings, monitor workshops and regional/local meetings, if applicable

· Participates in selected site visits with investigators site staff and CRO representatives in support of clinical trial execution and report back to study teams e.g., feasibility, start-up activities, enrolment, or escalated site issues

· Documents all site interactions and submit executed reports promptly

· Provides regional operational support and acts as Prothena point of escalation for investigator sites

· Participates in development of CTL Work Plans, report templates, scripts, presentations, trackers, and metrics for the CTL role

· May participate in Regulatory GCP inspections and/or audits at investigator sites as sponsor representative

· Contributes to process improvement initiatives when required

Requirements:

Education and/or Experience:

·

· Extensive experience in global clinical trial operations from industry or CRO required ( >10 years)

· Extensive hands-on experience with clinical trial recruitment and enrollment

· Extensive medical and scientific knowledge and clinical development understanding

· A working knowledge of ICH/GCP

Competencies and Attributes:

· Excellent communicator of technical and scientific information

· Excellent interpersonal skills and demonstrated collaborative as well as independent working style

· Team player with excellent people skills and strong customer focus

· Ability to build relation with the external medical community

· Proactive and self-motivated, ability to align activities with the clinical development plans

· Strong organizational skills with effective use of time and prioritization

· Cross cultural awareness and fluent in at least one commonly spoken language in addition to English

· Ability to manage a geographically assigned territory from a home-based office

· Willingness to travel 20-30% within the assigned region is required
Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – Courageous, Imaginative, Selfless, and Joyful

Job Types: Full-time, Fixed term
Contract length: 12 months

Pay: $70.00 – $120.00 per hour

Benefits:

• Work from home

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Sydney NSW: Reliably commute or planning to relocate before starting work (Required)

Work Authorisation:

• Australia (Preferred)

Expected Start Date: 16/08/2022