เงื่อนไขการค้นหา

ประสบการณ์:

4 ปีขึ้นไป

ทักษะ:

Research, Compliance, Finance, English

ประเภทงาน:

งานประจำ

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• o Data generated at site are complete, accurate and unbiased.
• o Subjects right, safety and well-being are protected.Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
• CORE Competency Expectations:Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Demonstrated ability to mentor/lead.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including independent management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment.
• Experience with conducting site motivational visit designed to boost site enrollment.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
• Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.
• Required:Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• B.A./B.S. with strong emphasis in science and/or biology.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Regular
• Not Applicable
• 02/28/2025A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
• Requisition ID:R332366.

ประสบการณ์:

5 ปีขึ้นไป

ทักษะ:

Meet Deadlines, Work Well Under Pressure, Business Development, English, Thai

ประเภทงาน:

งานประจำ

• Design and develop Learning Solutions & Learning Products to create new & meet market demand.
• Provide consulting services on People Capability Development and offer solutions to enable corporate client's People Transformation.
• Apply various business frameworks, tools, and best practices in the design process.
• Work closely with Expert Partners in various practice areas in co-designing both Functional/Technical (e.g. Business strategy, Venture strategy, Supply Chain Transformation, Digital Transformation, etc.) and Leadership (e.g. People Manager, Talent & Successor Planning, Agility & Resilience, etc.) Capability Development Solutions for corporate clients.
• Develop systems and tools for measuring the effectiveness of the solutions and present these insights to clients.
• Establish and manage strategic partnerships with learning technology partners to create modern and high-impact learning solutions.
• Lead the team with effective leadership, foster team development, and drive growth by cultivating a high-performance culture.
• MBA (Required).
• Strong expertise and experiences in Learning Solution & Learning Product Development.
• Highly proficient in both Thai and English (TOEIC > 900 Required, or other equivalent test).
• Highly result-oriented with can-do attitude and work-life integration mindset.
• Work Location.
• IRIS Consulting, 12A Pearl Bangkok, BTS Ari.