Senior Study Start-up Specialist - FSP

Job Purpose:

Functions as a subject matter expert on all Study Start-up (“SSU”)-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.

Main Responsibilities and Accountabilities:

1. SSU Coordination and Execution:

• Coordinate guide and assist with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (“ICF”) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (“EC”) information, meeting dates & costs. Ethics applications & associated online systems. Ethics & Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts & Indemnity request process. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes.QualificationsQualifications:

a. University Degree or Equivalent preferably in a medical/science-related field.

b. Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.

c. Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.

Skills, Experience and Competencies:

a. Demonstrated competence in analysis, planning and problem solving.

b. Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.

c. Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.

d. Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork.

e. Able to make effective decisions, self-motivated, assertive, and displays initiative

f. Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility.

g. Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.