GENERAL DESCRIPTION AND RESPOIBILITIES:

o Act as a key contact for the Spoor and Project(s)

o Lead, manage and communicate with multi-functional teams on regional or global interdisciplinary projectstudies to eure on-time, and within budget deliverables for projects

o Manage clinical projects to meet Company and Spoor requirements and satisfaction. This includes managing resources, budgets, milestones, timeline and quality

o Plan, initiate, develop and organise clinical trials in accordance to the highest standards required in the good clinical practices, regulatory obligatio, investigator integrity and compliance with study protocols and procedures

o Set up , maintain, execute and implement project-related documents, dossie and files, project databases, project timelines and processes, as well as tracking systems or other tracking/analysis tools for Spoor and Management

o Review , finalise and approve all study-related regulatory and administrative documents (including investigator study budgets and contracts) from investigator sites, monthly clientite invoices, monthly monitoring reports, work progression reports and other documents

o Plan and coordinate in regular study team meetings and present at the Investigator’s meetings , site initiation meetings and/or site close-out meetings

o Assess project resource requirements on a continual basis to eure appropriate resources are allocated

o Identify specific training needs and supervise, train and mentor project team/clinical research staff within the company on project related policies, procedures, project management tracking tools, and other relevant SOPs

o Work and coordinate directly with both pharmaceutical and biotechnology companies (collectively refe to spoo) with overall respoibilities for managing the budget, timelines, qualities of all aspects of the assigned clinical trials/projects

o Work closely with spoo to oveee the implementation of project specific procedures and requirements to eure that the study goals and expectatio (on-time, on-budget, quality performances) are met

o Measure and keep track team overall performance indices agait projected baselines, timeline and milestones to eure that all project work are completed and delivered to spoor’s requirements and satisfactio

o Resolve and recommend solutio and manage any deviation from plan or budget

This job description does not list all duties of the job. Employees may be asked by superviso or management to perform other duties.

MINIMUM REQUIREMENTS:

o Bachelor degree, major in nuing, pharmacy or other science-related background from a recognized ititution, and/or equivalent combination of training and experience

o Minimum 5 yea experience in clinical research, with at least 2 yea prior experience in managing projects

o Advance knowledge of ICH-GCP guidelines, local GCP guidelines and regulatio in the region

o Good undetanding of cross-functional processes, clinical trial processes and the regulatory environments

o Effective written and verbal communication skills, preferably with good command of English in addition to local language

o Good organizational, leadehip and interpeonal skills

o High integrity in peonality and professionalism

o Ability to manage time and work independently

o Positive attitude, high degree of initiative and committed

o Self-initiative to perform duties, with good analytical and problem-solving capabilities

o Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision

o Meticulous and able to work in a fast-paced environment Able to work under pressure and under challenging timelines when required

o Ability to travel when required