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Clinical Operations Director
2 months ago
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.
Key Responsibilities- Execute clinical trials, as per the Colombia and Mexico Book of Work, ensuring timely study start-up and meeting target subject recruitment numbers and database lock timelines.
- Evaluate clinical trial feasibility and site selection by collaborating with the BI&A and Medical country teams to assess current metrics and data.
- Endorse country and site feasibility targets for Colombia and Mexico.
- Manage the Mexico and Colombia team's workload and support of multiple studies, providing continuous assessment of resource needs and anticipating and initiating actions in response to multiple/changing demands and priorities.
- Take a broad business perspective when making decisions, ensuring work is achieved within target timelines, exercising sound judgement in areas of clinical trial management, resource allocation, and recruitment activities.
- Build and maintain a highly performing team of highly qualified, Mexico and Colombia based, research professionals and the respective line managers.
- Ensure effective utilization of FSP resources in the execution of clinical trials conducted in the Latam North Cluster.
- Meet or exceed 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 the most impactful manner.
- Support a GDO Quality Culture.
- Ensure a continuous improvement mindset across the group.
- 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 and stakeholders therein, both for Mexico and Colombia.
- Demonstrated organizational and planning skills and independent decision-making ability.
- Highly organized and motivated, possessing excellent communication, interpersonal, and presentation skills.
- Passionate, accountable, and innovative critical thinker who balances risk/speed for maximum results.
- Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide others.
- Results-oriented with a proven track record in building strong, collaborative relationships with internal and external stakeholders to manage the Latam North book of work.
- Good verbal and written communication skills (both in English and Spanish).
- Experience working with Public Institutions /Systems, both in Mexico and Colombia.
- Experience in participating/leading interactions with Regulators, Trade Associations, and Clinical Trial Associations both in Colombia and Mexico.
