Site Start Up Specialist (FSP)

Objectives/Purpose

• Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.
• Support sites and study teams to achieve rapid site start up.

Accountabilities

• Work directly with assigned sites on all site related essential document collection and review.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc.
• Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up.

Technical/Functional Expertise

• Understanding of the pharmaceutical industry (e.g., clinical development, the prescription drug distribution process, etc.)
• Understanding of Clinical Trial Agreements, budgeting and fair market value principals.
• Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.

Leadership

• Demonstrated ability to work across functions, regions and cultures.
• The ability to inspire, motivate and drive results.
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.
• Proven skills as an effective team player who can engender credibility and confidence within and outside the company.
• Ability to distil complex issues and ideas down to simple comprehensible terms.
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.

Decision-making And Autonomy

• Broad decision-making responsibilities:
• Ability to make decisions.
• Accountable for decision making for designated tasks.
• Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.
• Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution.

Interaction

• Effectively navigates the changing external and internal environment.
• Effectively represent the client in high-level negotiations with the ability to resolve conflict in a constructive manner.
• Takes the initiative and proactively resolves challenges with internal and external team members.

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity.

Education, Behavioural Competencies And Skills

• BS degree or international equivalent.
• 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and essential documents.
• Strong organizational skills, decision making, communication and negotiation skills.
• Proficient in Microsoft Excel, Word, and PowerPoint.

Pay Range

$67,000 - $70,000 USD Annually

Benefits

All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.

Learn more about our EEO & Accommodations request here.