![MSD](https://media.trabajo.org/img/noimg.jpg)
Clinical Research Manager
3 weeks ago
This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc.
**WHAT YOU WILL DO**
**Key Responsibilities**:
- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required.
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
- Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).
- Identifies and shares best practices across clinical trials, countries, clusters.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Country POC for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent company with investigators.
- Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
- Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed
**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, Biology or equivalent. An advanced degree would be advantageous (e.g., Master's degree, MD, PhD)
- Minimum of 5 years' experience in clinical research
- Knowledge in project management, site management and team management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head or CRD
- Requires strong understanding of local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Experience functioning as a key link between Country Operations and Clinical Trial Teams
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality, and project delivery.
- Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking. - Ability to work efficiently in a remote and virtual environment.
- Understand cultural diversity.
- The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring. Behavioral Competency Expectations: - Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of our Research & Development Division, Global Clinical Development (GCD) and GCTO.
- Ability to identify problems, conflicts, and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include:
- low pat
-
Clinical Research Associate
2 weeks ago
คลองเตย, กรุงเทพมหานคร, Thailand PRTR Full timeOur client is a global pharmaceutical company. They are looking for a Clinical Research Associate to join their team. **Responsibilities** - Functioning as project lead for complex BE/Phase I studies and small patient PK/clinical endpoint studies. Serve as liaison between the Mylan project team (Global Pharmacology, Product Development Department Chemistry...
-
Clinical Research Manager
2 weeks ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeMain Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). **Responsible for project management of the assigned studies**: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment,...
-
Clinical Research Associate
4 weeks ago
กรุงเทพมหานคร, Thailand Novotech Asia Full time**Minimum Qualifications & Experience**: Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical...
-
Clinical Research Manager
4 weeks ago
กรุงเทพมหานคร, Thailand MSD Full time**Job Description**: This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc. **WHAT YOU WILL DO** **Key Responsibilities**: -...
-
Clinical Research Manager
1 week ago
กรุงเทพมหานคร, Thailand MSD Full time**Job Description**: This position is responsible for project management of the assigned studies, accountable for performance for assigned protocols, leads local study teams to high performance on trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert etc. **WHAT YOU WILL DO** **Key Responsibilities**: -...
-
Research Nurse
3 days ago
ปทุมวัน, กรุงเทพมหานคร, Thailand มูลนิธิสถาบันเพื่อการวิจัยและนวัตกรรมด้านเอชไอวี Full timeองค์กรการกุศล วันนี้ - คุณสมบัติพื้นฐาน - งานประจำ- 3 - 5 ปี- กทม. (ปทุมวัน)- ปริญญาตรี- สามารถเจรจาต่อรองได้- หน้าที่และความรับผิดชอบ -...
-
Clinical Research Associate
2 weeks ago
กรุงเทพมหานคร, Thailand MSD Full time**THE OPPORTUNITY** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Clinical Research Associate
4 days ago
กรุงเทพมหานคร, Thailand MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...
-
Clinical Research Associate
5 days ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeDevelops 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...
-
Clinical Research Associate
3 weeks ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeDevelops 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...
-
Clinical Research Associate
3 weeks ago
กรุงเทพมหานคร, Thailand MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site...
-
Clinical Research Coordinator
4 weeks ago
กรุงเทพมหานคร, Thailand Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Clinical Research Associate Manager
3 weeks ago
กรุงเทพมหานคร, Thailand MSD Full time**Clinical Research Associate Manager** **THE OPPORTUNITY** This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Head of Monitoring Resources or the CRD, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations,...
-
Clinical Research Associate
2 weeks ago
สาทร, กรุงเทพมหานคร, Thailand PRTR Full timeMore than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people...
-
Clinical Research Associate Manager
1 week ago
กรุงเทพมหานคร, Thailand MSD Full time**Job Description**: **Clinical Research Associate Manager** **THE OPPORTUNITY** This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Head of Monitoring Resources or the CRD, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to...
-
Clinical Research Associate Manager
3 weeks ago
กรุงเทพมหานคร, Thailand MSD (THAILAND) LTD. Full timeWork 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...
-
Associate Clinical Research Manager
1 week ago
กรุงเทพมหานคร, Thailand MSD Full timeWith support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, the company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. The aCRM could be...
-
Senior Clinical Research Associate
4 weeks ago
กรุงเทพมหานคร, Thailand MSD Full time**Job Description**: **THE OPPORTUNITY** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements...
-
Senior Clinical Research Associate
2 weeks ago
กรุงเทพมหานคร, Thailand MSD Full time**THE OPPORTUNITY** The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Senior Clinical Research Associate
3 weeks ago
กรุงเทพมหานคร, Thailand MSD Full timeThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...