Clinical Operations Director
hace 2 meses
This role will be part of the Regional Clinical Operations (RCO), Latam North, R&D regional organization, and will be responsible for the execution of phase I-IV clinical studies in Colombia and Mexico.
About the RoleThis leadership position will serve as a member of the RCO LATAM Senior Leadership Team and be part of the RCO and GDO extended leadership teams. This role will also serve as a member of the local affiliate leadership team (as applicable) managed by the General Managers of the Countries, as well as other affiliate senior leadership committees.
Main ResponsibilitiesKey responsibilities include:
- Proactively evaluating clinical trial feasibility and site selection by collaborating with the BI&A and Medical country teams to evaluate current metrics and data.
- Managing the Mexico and Colombia team's workload and support of multiple studies. Provides continuous assessment of resource needs and anticipates and initiates actions in response to multiple/changing demands and priorities.
- Taking a broad business perspective when making decisions. Makes judgments to ensure work is achieved within target timelines. Exercises sound judgment in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities.
- Building and maintaining a highly performing team of highly qualified, Mexico and Colombia based, research professionals and the respective line managers.
- Ensuring effective utilization of FSP resources in the execution of clinical trials conducted in the Latam North Cluster.
- Meeting or exceeding project deliverables and initiatives with the highest quality through alignment with senior leaders and key stakeholders through flexible and fluid resourcing.
- Developing, maintaining and maximizing strong working relationships with peers, senior leaders, key stakeholders and external institutions/networks to influence decisions and achieve optimal results focused on our patients.
- Driving alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders.
- Identifying, maintaining and optimally growing clinical investigative site/Institution/Network relationships through direct/personal and/or group engagements in most impactful manner.
Required qualifications include:
- Bachelor's degree required preferably within life sciences or equivalent.
- Minimum of 10 years of experience in people and project management in a pharma/biotech/CRO organization.
- Significant experience in the planning, conduct and management of clinical programs (Phase I-IV).
- Demonstrated ability to drive project-related activities.
- Previous experience leading, managing, coaching and developing direct reports.
- In-depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs.
- Understands the drug development process, from early to late stage, including lifecycle management.
- Deep knowledge of clinical trial operations including monitoring methodologies, systems, regulations/compliance, budget and resource management and site-facing engagements.
- Knowledge of the external country clinical trial environment.
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