Job Summary:
As a Clinical Project Lead in Clinical Research and Development team this individual contributes with appropriate oversight to all aspects of global clinical trial(s) to deliver study outcomes within schedule budget quality/compliance and performance standards. He/she may lead specific aspects of global clinical trial(s). The Clinical Project Lead is a leader of the Clinical Sub Team and a core member of the Clinical Trial Team. He/she contributes to operational excellence through process improvement and knowledge sharing.
Key Responsibilities:
With R&D Core Team establishing the criterion essential for determining the safety efficacy and value of products
Confirming clinical research program design meets scientific objectives and is aligned with commercial needs
Gathering input from cross-functional teams and creating plans that help the team produce deliverables on schedule
Planning directing creating and communicating clinical study timelines
Ensuring study is conducted within clinical trial protocols
Overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP) good clinical practice (GCP) and specific country regulations
Participating in data analysis interpretation and synthesis instruction in order to develop Clinical study report and /or support development of scientific publications including peer reviewed manuscripts in partnership with external key opinion leaders (KOLs)
Knowledge and Skills:
Collaborates - Actively participates in and supports a collaborative team environment.
Plans and Aligns - Effectively manage studies on schedule.
Communicates Effectively - Good written verbal listening and presentation skills with ability to express thoughts in a clear and concise manner. Attentively listen to others.
Education/Work Experience:
Bachelors Degree or equivalent years of directly related experience (or high school13 yrs; Assoc.9 yrs; Bach.5; M.S.2 yrs; PhD0 yrs)
5 years of relevant experience