SKILLS (ESSENTIAL):

• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent attention to detail.
• Proficient in written and spoken English language required.
• Fluency in local language(s) required.
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.

SKILLS (DESIRABLE):

• Good analytical skills.
• Good resource management skills.
• Good decision making and delegation skills.
• Good financial management skills.
• Basic change management skills.
• Basic coaching skills.
• Basic ability in handling crisis situations.

KNOWLEDGE AND EXPERIENCE (ESSENTIAL):

• Minimum 3+ years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH GCP as well as relevant local regulations.

KNOWLEDGE AND EXPERIENCE (DESIRABLE):

• Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• Very good understanding of the Study Drug Handling Process and the Data Management Process.
• Good intercultural awareness.

EDUCATION:

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

REGULATORY AND SITE START UP RESPONSIBILITIES

• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.