Job Description

Company DescriptionWe are the company that cares xe2x80x93 for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.PSIxe2x80x99s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.Wexe2x80x99re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level.You will become one of our first team members in Malaysia and contribute to the development of PSI Operations.You will:

• Supervise study activities, timelines, milestones, and schedules on the country level.
• Conduct and report all types of onsite monitoring visits.
• Be involved in study set-up, including site contract and budget negotiations.
• Be responsible for site communication and management.
• Ensure consistency of all study processes and identify country differences.
• Oversee maintenance of study-specific and corporate tracking systems.
• Contribute to the development and update of project planning documents, essential documents, and project instructions.
• Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Development of local language materials including local language Informed Consents and translations.
• Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

QualificationsThe ideal candidate must possess the following qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred.
• Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise.
• Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.
• Proficiency in feasibility assessment and study set-up processes is highly desirable.
• Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.
• Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment.
• Superior communication, collaboration, and problem-solving skills are essential.
• Willingness and ability to travel extensively within Malaysia is a prerequisite for this position.

Additional InformationHow are we different?PSI is privately owned by the very people who founded the company more than 25 years ago, and theyxe2x80x99re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.Growth OpportunitiesPSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.

PSI CRO