เงื่อนไขการค้นหา

ประสบการณ์:

5 ปีขึ้นไป

ทักษะ:

Research, Finance, Compliance, English

ประเภทงาน:

งานประจำ

• Work allocation, staff development and performance appraisal.
• Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.
• Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.
• Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM.
• Attend local Investigator Meetings if requested to.
• Interface with team partners on clinical trial execution.
• Escalates site performance issues to CRM and Clinical Research Director CRD.
• People and Resource Management.
• Manage CRA - career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.
• Support and resolve escalation of issues from CRAs.
• Liaise with local HR and finance functions as required.
• Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.
• Provides training, support and mentoring to the CRA to ensure continuous development.
• Ensures CRA compliance to corporate policies, procedures, and quality standards.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• Bachelor's degree in Science.
• Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology.
• Minimum of 5 years experience within Clinical Research.
• Minimum of 3 years' experience as CRA monitoring clinical trials.
• Line management experience preferred or at the minimum team leader experience.
• CORE Competency Expectations:
• Ability to work independently and in a team environment.
• Excellent people management, time management, project management and organizational skills.
• History of strong performance.
• Skills and judgment required to be a good steward/decision maker for the company.
• Fluent in Local Language and business proficient in English (verbal and written).
• Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines.
• Expertise in and excellent working knowledge of core trial management systems and tools.
• Behavioral Competency Expectations:
• High emotional intelligence.
• Strong leadership skills with proven success in people management.
• Excellent interpersonal and communication skills, conflict management.
• Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators).
• Influencing skills.
• CORE Competency Expectations:Ability to work independently and in a team environment.
• Excellent people management, time management, project management and organizational skills.
• History of strong performance.
• Skills and judgment required to be a good steward/decision maker for the company.
• Fluent in Local Language and business proficient in English (verbal and written).
• Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines.
• Expertise in and excellent working knowledge of core trial management systems and tools.
• Behavioral Competency Expectations:High emotional intelligence.
• Strong leadership skills with proven success in people management.
• Excellent interpersonal and communication skills, conflict management.
• Demonstrated ability to build relationships and to communicate effectively with external customers (e.g. sites and investigators).
• Influencing skills.
• Experience Requirements:
• Required:Minimum of 5 years experience with in Clinical Research.
• Minimum of 3 years' experience as CRA monitoring clinical trials.
• Line management experience preferred or at the minimum team leader experience.
• Educational Requirements:
• Required:Bachelor's degree in Science.
• Preferred:Advanced degree, (e.g. BA/BS or higher) with a 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.
• Employee Status:
• Regular
• Relocation:
• Domestic
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Not Applicable
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Job Posting End Date:
• 06/4/2024A 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.
• Job Posting End Date:06/04/2024.
• A 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:R295312.

ประสบการณ์:

5 ปีขึ้นไป

ทักษะ:

Compliance, Research, Biology, 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.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased.
• 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 and if applicable, RCPM.
• 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.
• Could perform Quality control visits if delegated by other roles and trained appropriately.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• Bachelor of Sciences with strong emphasis in science and/or biology would be preferred.
• Minimum 4-5 Years of clinical research experience which may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC etc.
• 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 Clinical Research Guidelines and ability to work within these guidelines.
• Developing skills in Site Management including management of site performance and patient recruitment which 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.
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
• 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.
• Employee Status:
• Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Remote
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Job Posting End Date:05/31/2024.
• A 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:R257594.

ประสบการณ์:

2 ปีขึ้นไป

ทักษะ:

Research, Compliance, Biology, 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.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased.
• 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, and RCPM.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices 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.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• Bachelor of Sciences with strong emphasis in science and/or biology would be prefer.
• Minimum 2 Years of clinical research experience which may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC etc.
• 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 Clinical Research Guidelines and ability to work within these guidelines.
• Developing skills in Site Management including management of site performance and patient recruitment which 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.
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• 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.
• Employee Status:
• Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Not Applicable
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Job Posting End Date:
• 06/20/2024A 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.
• Job Posting End Date:06/20/2024.
• A 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:R266104.