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 or 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.