Clinical Research Manager
hace 3 semanas
**Job Description**:
**Clinical Research Manager (CRM)**
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.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
**Clinical Research Manager**
This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonisation Good Clinical Practice and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The Clinical Research Manager could be responsible for a particular study for several countries in a cluster.
**Responsibilities include, but are not limited to**:
- Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team.
- 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 International Council for Harmonisation Good Clinical Practice and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
O Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate manager and/or functional vendor and internal management as needed.
O 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 Clinical Research Associate as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with Clinical Trial Management System, electronic Trial Master File and other key systems in assigned studies.
- Escalates as needed different challenges and issues.
- 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 point of contact for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent the 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 Clinical Research Director, Therapeutic Head and Regional Operations.
- Collaborates internally with Headquarters functions, regional and local operations, Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials.
**Core Competency Expectations**:
- Knowledge in Project Management and site 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 therapeutic head or Clinical Research Director
- 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. -Und
-
Clinical Research Manager
hace 5 días
Bogota, Colombia MSD A tiempo completo**Job Description**: 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...
-
Clinical Research Associate
hace 1 día
Bogota, Colombia MSD A tiempo completoThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and procedures, quality...
-
Clinical Research Associate
hace 6 días
Bogota, Colombia MSD A tiempo completo**Job Description**: 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/MSD policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Senior Clinical Research Associate
hace 4 semanas
Bogota, Colombia 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 or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts...
-
In-house Clinical Research Associate I
hace 2 días
Bogota, Colombia Labcorp A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Clinica Research Associate
hace 4 semanas
Bogota, Colombia MSD A tiempo completo**Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and...
-
Site Research Assistant in Bogotá
hace 6 días
Bogota, Colombia Novasyte A tiempo completoGreat opportunity if you want to join one of the greatest CROs! Job Overview Perform a variety of administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. Essential Functions - Provide clinical research support to...
-
Clinical Trial Administrator Ii
hace 4 semanas
Bogota, Colombia PSI CRO A tiempo completoCompany Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Join our international team and be the...
-
Clinical Operations Lead
hace 1 día
Bogota, Colombia Amgen A tiempo completo**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...
-
Clinical Research Associate Ii
hace 2 días
Bogota, Colombia Labcorp A tiempo completoThe Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project...
-
Clinical Trial Administrator Ii
hace 4 días
Bogota, Colombia PSI CRO A tiempo completoCompany Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Join our international team and be the...
-
Sr Clinical Research Associate Ii
hace 4 semanas
Bogota, Colombia PSI CRO A tiempo completoCompany Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...
-
Assoc Clinical Specialist
hace 6 días
Bogota, Colombia Medtronic A tiempo completo**Careers that Change Lives **A Day in the Life Responsibilities may include the following and other duties may be assigned. - Conducts on-site education and / or consulting. - Supports field personnel in providing the best possible outcomes and service for Medtronic customers. - Partners with sales colleagues to develop and execute plans of sales for within...
-
Project Manager, Research
hace 7 días
Bogota, Colombia International Rescue Committee A tiempo completo**Requisition ID**: req41808 **Job Title**: Project Manager, Research & Innovation **Sector**: Program Administration **Employment Category**: Regular **Employment Type**: Full-Time **Compensation**: USD 65,000.00 - 85,000.00 Salary **Location**: New York, NY HQ USA **This position can be fully remote in all US IRC Locations.** We are looking for an...
-
Site Management Assistant
hace 7 días
Bogota, Colombia IQVIA A tiempo completoJob Overview Provide centralized task support on all assigned projects. Ensure all work is conducted in accordance with SOPs, work instructions, policies, good clinical practices and applicable regulatory requirements. Comply with all associated quality and timeliness metrics. Essential Functions - Liaise with project teams and third party vendors to...
-
Bogota, Colombia Novasyte A tiempo completoJoin us as a Site Activation Coordinator! What You´ll Do Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. Support in all tasks related...
-
Evidence Synthesis Associate Consultant
hace 4 semanas
Bogota, Colombia IQVIA A tiempo completoJoin our team as an **Evidence Synthesis Associate Consultant** supporting rigorous analyses and critical appraisals of published medical evidence across a wide range of diagnostic, prognostic, therapeutic, and other clinical interventions, as well as drafting reports. This professional will also provide technical expertise on evidence synthesis methods,...
-
Bogota, Colombia IQVIA A tiempo completo**Join us as a Site Activation Coordinator**!**: **What You´ll Do**: Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. Support in all tasks...
-
Msl Derma
hace 1 día
Bogota, Colombia ABBVIE A tiempo completoMedical Science Liaisons (MSLs) are key members of the affiliate medical department. These field-based roles focus on medical and scientific engagement with AbbVie stakeholders (including research and healthcare professionals, payers, and providers). The focus of this role is on interacting with, and supporting the needs of, Tier 1 and 2 thought leaders, but...
-
Msl - Oncology
hace 4 semanas
Bogota, Colombia IPSEN A tiempo completo**Title**: MSL - Oncology **Company**: Ipsen Pharma (SAS) The MSL is a member of the affiliate medical department. He/she is a field-based professional (Hybrid role for Colombia define by 80%) with scientific, clinical and therapeutic area expertise who is responsible for supporting, on a non-promotional basis, medical and scientific initiatives for...