Sr. Clinical Research Associate
hace 4 días
Are you an experienced Clinical Research Associate looking for a new opportunity to excel in your career? Join our dynamic team and make a difference in the field of clinical research. We are seeking a highly motivated and detail-oriented individual to oversee and manage clinical research protocols and sites in Argentina. As a Clinical Research Associate, you will play a crucial role in ensuring compliance with regulations, company policies, and quality standards.
**Responsibilities**:
- Develop strong site relationships and ensure continuity throughout all phases of the trial.
- Perform clinical study site management activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, and protocol requirements.
- Gain in-depth understanding of study protocols and related procedures.
- Coordinate and manage tasks in collaboration with other sponsor roles to achieve site readiness.
- Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
- Communicate with investigators and site staff on protocol conduct, recruitment, retention, and regulatory compliance.
- Identify and resolve site performance, quality, or compliance issues in collaboration with relevant stakeholders.
- Work collaboratively with internal teams and external partners in support of assigned sites.
- Manage and maintain information and documentation in various systems.
- Support audit and inspection activities as required.
- Contribute to the identification and development of new potential sites.
**Requirements**:
- Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO.
- Fluent in local languages and English (verbal and written) with excellent communication skills.
- Excellent understanding of clinical research, GCP/ICH guidelines, and country-specific regulations.
- Demonstrated ability to mentor and lead.
- Ability to analyze data/metrics and take appropriate action.
- Experience with site motivational visits to boost enrollment.
- Capable of managing complex issues and implementing corrective action.
- B.A./B.S. with strong emphasis in science and/or biology preferred.
**Why Join Our Team**:
- Opportunity to work in a dynamic and growing company at the forefront of clinical research.
- Collaborative and supportive work environment.
- Growth and development opportunities.
- Competitive salary and benefits package.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
No
**Travel Requirements**:
10%
**Flexible Work Arrangements**:
Not Applicable
**Shift**:
Not Indicated
**Valid Driving License**:
No
**Hazardous Material(s)**:
no
**Job Posting End Date**:
11/4/2024
**Requisition ID**:R307152
-
Clinical Research Associate
hace 18 horas
Munro, Argentina MSD A tiempo completoOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and...
-
(Finance) Clinical Trial Coordinator
hace 18 horas
Munro, Argentina MSD A tiempo completoUnder the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The role is critical to meet planned Site Ready dates. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with...
-
Reports Programmer
hace 7 días
Munro, Argentina MSD A tiempo completo**Job Description**: Our organization is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination,...
-
Cra
hace 18 horas
Munro, Argentina MSD A tiempo completoThe 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, company´s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...
-
Msl General Medicine
hace 2 días
Munro, Argentina MSD A tiempo completoMedical Science Liaison Specialist (MSL Specialist) is a credentialed therapeutic and disease expert who engages in scientific exchange with leaders in the external medical and scientific community. The role provides scientific leaders (SLs) balanced, factual, scientific information about non-product areas of interest to the Company and replies to scientific...
-
Cra Junior
hace 18 horas
Munro, Argentina MSD A tiempo completoWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring...
-
Ram Mapping Programmer Ii
hace 3 días
Munro, Argentina MSD A tiempo completoPrimary activities include, but are not limited to: Assumes the responsibilities for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs. Coordinates and participates in the following activities: 30% Design, build, maintain, test, and document data mapping specifications based on...
-
Reports Programmer Analyst
hace 2 días
Munro, Argentina MSD A tiempo completo**Job Description**: Skills) - Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills) Primary activities include, but are not limited to: Assumes the responsibilities for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs. Coordinates...
-
Cra Manager
hace 1 semana
Munro, Argentina MSD A tiempo completoThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, 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, company SOPs and ICH GCP. As line manager the role is...
-
Talent Acquisition Sr Analyst Winclap
hace 2 días
Munro, Argentina INHAUS A tiempo completoWe are looking for a **Talent Acquisition Sr Analyst** for growing company. Winclap is a team of technologists, entrepreneurs, mobile app enthusiasts, excited to help the mobile app community move into from data-driven marketing to AI-driven marketing. **Responsabilities**: - Manage full cycle recruiting process, creating innovative sourcing strategies and...
-
Medical Science Liaison
hace 18 horas
Munro, Argentina Bayer A tiempo completo**Medical Science Liaison (MSL) Oncology** At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us,...
-
Medical Science Liaison
hace 18 horas
Munro, Argentina Bayer A tiempo completo**Medical Science Liaison (MSL) Cardio Renal** At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where, Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around...
-
Senior Technical Project Manager
hace 2 días
Munro, Argentina MSD A tiempo completo**Job Description**: The Sr. Technical PM is responsible for the oversight and management of the end-to-end delivery of technical data management components for one or more drug/vaccine programs. Provides technical consultation on the data management strategy, collaborates with appropriate functional areas to secure and align resources, and ensures all...
-
L-com
hace 18 horas
Munro, Argentina MSD A tiempo completoThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...
-
Edao Analyst Ii
hace 3 días
Munro, Argentina MSD A tiempo completo**Job Description**: Create, review, and facilitate approval of external data format specification documents for new vendors and data types. Coordinate with external vendors, Information Technology (IT), and the other supporting functions to validate external data transfers into our organization’s data management system in accordance with detailed...
-
Edao Analyst
hace 18 horas
Munro, Argentina MSD A tiempo completo**Job Description**: **Reporting directly to Head/Manager of eClinical Technologies, the EDAO Analyst** will create, review, and facilitate approval of external data format specification documents including, but not limited to; Data Transfer Specifications (DTS) & Electronic Data Transfer (eDT). Coordinate with external vendors, Information Technology (IT),...
-
Legal Sr Analyst
hace 1 semana
Munro, Argentina PepsiCo A tiempo completoOverview: PepsiCo products are enjoyed by consumers more than one billion times a day in more than 200 countries and territories around the world. PepsiCo generated more than $79 billion in net revenue in 2021, driven by a complementary beverage and convenient foods portfolio that includes** LAY’S ®, DORITOS ®, CHEETOS ®, GATORADE ®, PEPSI ®, QUAKER...
-
Admin Assistant Iv
hace 1 semana
Munro, Argentina IGT A tiempo completoLocation: Munro, AR, 1605- Requisition ID: 10863**Responsibilities**: - Provides analytical and specialized administrative support to relieve executive, administrative, and line and staff managers of complex details and advanced administrative duties. - Executes special or continuous research and data analysis tasks. - Analyzes problems, determines...
-
Cdt Analyst Ii
hace 5 días
Munro, Argentina MSD A tiempo completoUnder the direction of the Director/Associate Director, the CDT Analyst II creates and executes Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes: internet based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc. along with reporting and documenting testing results....
-
Sc Sr Resource
hace 18 horas
Munro, Argentina PepsiCo A tiempo completoOverview: **PepsiCo products are enjoyed by consumers more than one billion times a day in more than 200 countries and territories around the world. PepsiCo generated more than $79 billion in net revenue in 2021, driven by a complementary beverage and convenient foods portfolio that includes LAY’S ®, DORITOS ®, CHEETOS ®, GATORADE ®, PEPSI ®, QUAKER...