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Job Summary:
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
This role will lead the Latam North Cluster clinical operations teams and is responsible for execution excellence in operational planning, implementation, trial management, site management and monitoring of clinical trials (registrational, non registrational / Investigator Sponsored Research (ISR)) conducted within Colombia and Mexico. This leadership role 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. This role will interact with the development teams, local medical and key BMS stakeholders in order to ensure effective management of Latam North conducted clinical trials. This role will support a GDO Quality culture collaborating with both the GDO Global Clinical Compliance team as well as the GQ Clinical Trial and Safety group
**Responsibilities**:
- Proactively evaluates clinical trial feasibility and site selection by collaborating with the BI&A and Medical country teams to evaluate current metrics and data.
- Endorses country and site feasibility targets for Colombia and Mexico
- Manages 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.
- Takes a broad business perspective when making decisions. Makes judgements to ensure work is achieved within target timelines. Exercises sound judgement in areas of clinical trial management, resource allocation (headcount and budget targets) and recruitment activities.
- Builds and maintains a highly performing team of highly qualified, Mexico and Colombia based, research professionals and the respective line managers.
- Managing the hiring, development, coaching, mentoring, performance management and succession planning of staff.
- Ensures 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.
- Develop, maintain and maximize strong working relationships with peers, senior leaders, key stakeholders and external institutions/networks to influence decisions and achieve optimal results focused on our patients.
- Drive alignment across development programs promoting knowledge sharing, operational issue resolution through close collaboration with key stakeholders.
- Identify, maintain and optimally grow clinical investigative site/Institution/Network relationships through direct/personal and/or group engagements in most impactful manner
- Supports a GDO Quality Culture
- Ensures a continuous improvement mindset across the group.
- Supervisory Responsibility for line management of Clinical Trial Managers, Clinical Trial Monitors, Clinical Trial Associates, Study Start-up and Site Contract Lead, Trial Managers - Late Development and Trial Specialists - Late Development role
**Required Qualifications**
- Bachelors 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 envi
