Clinical Operations Lead

hace 3 semanas

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 ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

**Clinical Operations Lead (Bogotá)**

**Live**:
**What you will do**

**Key responsibilities include, but are not limited to**:

- Oversight of clinical trials processes and operations according to the strategic imperatives of the affiliate.
- Detailed knowledge of the planning process, feasibility, initiation (contracts, policies, ethics committee), implementation (enrollment follow-up, support strategies), follow-up and closure of clinical studies; as well as ensuring compliance with the approval and start-up times of clinical studies and enrollment metrics determined through liaison with the different local and regional teams involved in the process.
- Guarantee timely and strategic relationship with team members (SCBA, LTM, GRASS, DFM, CTOM) and partners (CRO, INVIMA, AFIDRO, AVANZAR, SITES) related to clinical studies and generation of insights that will be shared to the internal team to develop actionable actions in this regard.
- Establish and lead the oversight strategies to increase local allocation of strategic clinical trials, increase enrollment rate and improve start up process.
- Execute local RWE projects in conjunction with medical advisor and the evidence generation head.
- Identify the evidence gaps across the different molecules in oncology, hematology, and general medicines.
- Guarantee strategic alignment with the local and regional regulatory team, as well as timely monitoring of clinical study approvals with the local regulatory entity (INVIMA)
- Guarantee that the database of research sites is signalized and updated with the operational, logístical, and training capabilities to propose them during the feasibilities.
- Guarantee relationship and scientific link with AFIDRO and AVANZAR clinical studies group to generate strategies around the optimization of local processes.
- Global monitoring of molecules in the pipeline and clinical development status for local review of potential feasibility according to the local strategy. Timely and periodic alignment with Scientific Head/Medical Advisors for review of current pipeline and review of interest according to local strategy.
- Guarantee expertise in knowledge of the different research protocols and molecules under study, as well as training the medical team in the generality of key studies for the company and socializing their strategic importance in the future.
- Guarantee the mapping and stratification of research centers at the national level, documenting clinical and operational leaders, focus areas, ethics committee, GCP status and contact information, as well as ensuring that the database is kept updated with this information.
- Responsible for reviewing updates to the local SOP of non-promotional materials and ensuring its socialization and training in a timely manner, as well as being the POC for requests related this procedure.
- Responsible to define and implement local RWE initiatives.

**Outputs**:

- Monthly reports/presentations to local medical team and regional CT team.
- Weekly meetings/presentation with CRO LTMs.
- Accurate and updated oversight registry of active and planning clinical trials database.
- Quarterly report of clinical research workflow to the management team.
- RWE local committee KPIs.

**Win**:
**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.

**Basic Qualifications**:

- Doctorate degree OR
- Master’s degree in health-related area (RN, PharmD, BSc, MD) and 2 years of experience in Clinical trials monitoring and execution
OR
- Bachelor’s degree in health-related area (RN, PharmD, BSc, MD) and 4 years of experience in Clinical trials monitoring and execution OR
- Associate’s degree in health-related area and 8 years of experience in Clinical trials monitoring and execution OR
- High school diploma / GED 10 years of experience in Clinical trials monitoring and execution.
- Proficiency in English, both in written and verbal communication.

**Preferred Qualifications**:

- Epidemiology/Statistics MsC/specialization.
- Practical experience in patient care, global and local clinical research policies.
- Excellent verbal and written communication skills
- Successful track record of managing multiple projects and competing priorities.
- Solid skills in conducting comprehensive literature searches and in critically appraising scientific literature to guarantee the timely response of feasibilities.
- Sound working know

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