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Job Description
Key Responsibilities: Feasibility and Site Identification:
- Site List Development: Work closely with the Global Feasibility Lead to develop the initial site list for feasibility and site identification, ensuring alignment with program or protocol requirements.
- Feasibility Process Management: Oversee the entire feasibility and site identification process, including survey development, programming, training, site outreach, progress reporting, and decision-making tools.
- Collaboration: Collaborate with Global Feasibility Leads to collect feedback from countries and investigators in the pre-award phase, summarizing and analyzing results.
- Site Profile Evaluation: Work with strategy and start-up teams to understand the optimal site profile and evaluate potential site sources, considering their advantages and disadvantages.
- Timeline Target Site Management: Manage timelines and track changes to target site list requirements to ensure that the target number of potential sites in each region and country is achieved.
- Master Data Coordination: Assist in facilitating identity matching by coordinating triggers for master data management.
- Survey Creation Data Accuracy: Create and manage electronic surveys using company software and ensure the accuracy and quality of survey-driven data.
- Literature and Internet Searches: Conduct necessary literature and internet research to support site identification efforts.
- Risk Identification Contingency Planning: Work with senior staff to identify potential risks, out-of-scope activities, and discuss contingency plans with stakeholders.
Training Cross-Functional Collaboration:
- Training Development Delivery: Develop and deliver training on feasibility and site identification requirements and processes to internal teams.
- Liaison with Cross-Functional Teams: Coordinate with global teams, including legal, clinical, start-up, country teams, and project management to ensure smooth execution of feasibility and site identification processes.
- Audit Support: Contribute to audit presentations and documentation related to site identification oversight.
Other Responsibilities:
- Perform any additional duties as assigned, supporting the overall success of the feasibility and site identification process.
Qualifications: Required:
- Education: Bachelor s degree in life sciences, business, or related field, or equivalent combination of education and experience.
Experience:
- Proven experience in feasibility, site identification, or clinical research, preferably within a CRO or pharmaceutical/biotech setting.
- Strong understanding of clinical trial processes, including site selection and feasibility assessments.
- Experience developing and managing surveys and site lists for clinical trials.
- Ability to analyze and interpret data, with a focus on quality and accuracy.
- Experience collaborating with cross-functional teams and managing multiple stakeholders.
- Strong organizational skills and ability to manage timelines effectively.
- Comfort with technology and using electronic data management systems.
Preferred:
- Certifications: Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
- Experience with Global Feasibility Process: Prior experience in global feasibility and site identification across multiple therapeutic areas is highly desirable.
What You Will Get:
- Competitive salary based on skills and experience.
Comprehensive Benefits Package including:
- Health insurance (Medical, Dental, Vision)
- Life Insurance, STD/LTD
- 401(K) plan
- Paid Time Off (PTO) or Flexible Time Off (FTO)
- Employee Stock Purchase Plan (ESPP)
- Company bonus (where applicable)