Minimum of 3-5 years of project management experience in the pharmaceutical, biotechnology, or clinical research industry.
Strong experience in managing clinical trials utilizing eCOA systems (e.g., ePRO, eConsent, and other electronic data capture solutions).
Proven expertise in managing Digital Clinical Trials (DCT), including the use of remote monitoring, telemedicine, wearable devices, and patient-centric solutions.
Technical Knowledge:
Strong understanding of eCOA platforms, clinical trial management systems (CTMS), and data management systems.
Familiarity with digital trial technologies (e.g., wearables, telemedicine tools, mobile apps) and remote patient monitoring platforms.
Knowledge of regulatory requirements for eCOA and DCT, such as 21 CFR Part 11, ICH E6, and HIPAA compliance.
Project Management Expertise:
Excellent project management skills, including scope definition, budgeting, timeline management, and risk assessment.
PMP (Project Management Professional) or other relevant certifications preferred.
Ability to manage multiple projects simultaneously while meeting deadlines and maintaining quality standards.
Communication & Leadership:
Strong communication, presentation, and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
Proven leadership skills with the ability to manage cross-functional teams and external vendors effectively.
Problem Solving & Analytical Thinking:
Strong problem-solving abilities, with a proactive approach to identifying and resolving issues.
Ability to analyze complex data and provide actionable insights to stakeholders.
Education:
A Bachelor’s degree in Life Sciences, Clinical Research, or a related field is required.
A Master’s degree or relevant certifications (e.g., Clinical Research Coordinator, Clinical Research Associate) is a plus.