Job Level & compensation offered may vary depending on candidates’ experiences and competencies.
- Leads the project team to facilitate the successful design, implementation, tracking and maintenance of all project plans, adhering to professional standards and SOPs, according to contracted timelines and budget
- Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of the TMF per agreed upon timelines, when contracted by client
- Proactively lead quality control and risk assurance activities to meet regulatory, internal and client requirements
- Fosters positive client experiences through effective communication and collaboration
- May serve as a primary contact for a strategic client relationship. Develops and manages strategic relationship level metrics. Initiates process improvement to address variance.
- Designs delivery strategy for large scale bid defense and performs other business development activities.
- Responsible for developing and maintaining client relationships and acquiring new business\
- Mentors junior staff
- All other duties as needed or assigned
Qualifications (Minimum Required):
- Fluent in English, both written and verbal
- Comprehensive knowledge of the clinical development spectrum and ICH GCP
- Expert level organizational and time management skills
- Proven critical thinking and problem-solving skills with a proactive approach to identifying and resolving project related issues
- Effective presentation skills for staff at all levels, including internal leadership and external partners
- Actively participates in organizational initiatives
Experience (Minimum Required):
- University/college degree (life science preferred)
- Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO including at least four (4) years of full project management responsibility
- In lieu of above experience requirement, a combination of other relevant and equivalent experience may be considered
