FSP Site Start Up Specialist
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
- 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 (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- 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 (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
- 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 (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
- Effectively navigates the changing external and internal environment
- Effectively represent Takeda 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 (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- 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.