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Experience:
2 years required
Skills:
Research, Compliance, Finance, English
Job type:
Full-time
Salary:
negotiable
- 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 protectedConducts 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 with 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.
- Supports audit/inspection activities as needed.
- Performs co-monitoring where appropriate.
- Competency Expectations:Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Developing skills in Site Management including management of site performance and patient recruitment.
- Developing level of monitoring skill and independent professional judgment.
- Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Works with high quality and compliance mindset.
- Capable of managing complex issues, solution-oriented approach.
- Ability to perform root cause analysis and implement preventative and corrective action.
- B.A./B.S. required with strong emphasis in science and/or biology.
- Min. 2 years of clinical research experience. Related CR experience.
- 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:R332376.
1 day ago
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Experience:
8 years required
Skills:
Research, Compliance, Risk Management, English
Job type:
Full-time
Salary:
negotiable
- Gather and analyze related data on debt securities/counterparties and foreign countries with the aim of conduct credit analysis, evaluate internal credit score/rating, key risks/drivers and mitigations for appropriate credit limit/tenor.
- Monitor and report daily CDS (Foreign Countries and Banks), rating & outlook (foreign countries, Thai and foreign banks, Thai and foreign corporates), stock price/index (countries, foreign banks and corporates).
- Attend company roadshow, analyst meetings and company visit, to study insights and g ...
- Conduct credit review in a timely manner and ensure full compliance of approval terms and covenants.
- Conduct credit opinion in case of outside SCBAM universe and review credit summary and credit rating.
- Prepare credit presentation and make analysis defend to Senior Management and Risk Management Committees.
- Work collaboratively with other SCBAM & SCB departments to provide information for credit rating agency (Fitch Rating) and review fitch credit rating report of SCBAM.
- Implement investment policy and guidelines and review credit risk management policy.
- Qualification Bachelor s Degree or higher in Finance, Economic, Accounting, Engineering.
- At least 8 year working experience as Credit Analyst, Credit Research Analyst, Fixed Income Analyst.
- Self-motivated/hard-working and interested in global economic.
- Good analytical, writing and presentation skills and able to handle work in time constraint.
- Good communication skill and strong leadership skill.
- Good command in English.
- Good computer literacy.
- Experienced in financial modeling would be an advantage.
- We're committed to bringing passion and customer focus to the business. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us.
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