Description
RESPONSIBILITIES- Working with large scale vendors (CRO, Central Laboratories, IXRS, etc.) in a global environment.
- Line management and/or mentoring experience of Jr. CRAs and Clinical Assistants: monitoring/mentoring skills expressed by calm and thorough review of situations. Proactively identifies and/or addresses problems.
- Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolution
- Function independently, take initiative and collaborate in process improvement activities and teams
- Constructively influence the decision making process:timely escalation of issues with solution based approach, adequate identification of key stakeholders and decision makers throughout, demonstrates by example, proactive problem solving abilities and follow through
- Exhibits proficiency in all aspects of monitoring, co-monitoring, teaching, and training
- Work with EDC and upfront data quality implementation procedures
- Understand the clinical development plan and how the individual projects are impacted
- Travel as needed (20-25%)
- Communicate across all departments within company.
REQUIREMENTS
- Bachelor's degree in biological science preferred.
- 4-6 years industry experience
- Minimum 4 years clinical research experience
- 3 years experience working with solid tumors:Possesses record of strong therapeutic experience, Ability to relate to and discuss disease and treatment process, can demonstrate core knowledge of RECIST and stand of care within disease area
- High proficiency and extensive experience managing large scale vendors (CRO, Central Laboratories, IXRS, etc.) in a global environment
- Strong experience with EDC and upfront data quality implementation
- Exhibits significant positive participation:takes direction well, possesses the ability to define and meet requirements, displays flexibility for improvement and creating solutions.
- Demonstrates high proficiency and extensive experience managing
- Ability to function independently, take initiative and collaborate in process improvement activities and teams
- Ability to constructively influence the decision making process:timely escalation of issues with solution based approach, adequate identification of key stakeholders and decision makers throughout
- Demonstrates, by example, proactive problem solving abilities and follow through
- Exhibits proficiency in all aspects of monitoring, co-monitoring, teaching, and training
- Displays strong written and verbal communication skills
- Combination of educational and work experience providing competencies to perform the required accountabilities specific to position.
- Proficient with Microsoft Office Suite Software