Manager, Site Engagement

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Establish and cultivate relationships with investigational sites, serving as the primary liaison between the company and these sites, while enhancing awareness of client compounds among investigators and site staff.

• Collaborate with global and local teams to devise and execute a strategic plan aimed at elevating the company’s profile and its global clinical development initiatives with both current and prospective investigators.

• Conduct independent evaluations of investigational sites to expand the company’s network.

• Actively engage with Medical/Patient/Industry Associations to strengthen the company’s network and promote its clinical trials.

• Acquire knowledge regarding site capabilities and historical performance to evaluate their suitability for participation in client clinical trials.

• Maintain consistent communication with the local organization to ensure alignment with KTLs and other pertinent local/regional stakeholders.

• Supervise site-level study initiation, execution, and closure activities delegated to CRO(s) for global programs across various Therapeutic Areas.

• Assist in negotiations for Site Agreements, encompassing both stand-alone and Master Site Agreements.

• Identify patterns, challenges, and risks across sites, collaborating with external vendors and the internal Trial Team to address and mitigate these issues.

• Work in conjunction with external vendors and the internal Trial Team to ensure timely site activation in accordance with established timelines.

• Partner with external vendors and the internal Trial Team to guarantee that sites meet anticipated recruitment goals, which includes identifying causes for non-recruitment and pinpointing underperforming sites that necessitate intervention.

• Ensure compliance with ICH/GCP and local regulatory requirements.

• Provide documented oversight for sponsor sites at the country level for outsourced trials, as mandated by regulations.

• Leverage site performance and quality data to enhance the prioritization of oversight actions.

⛳️ Requirements

• Comprehensive understanding of all facets of clinical protocol design and implementation, as well as clinical site monitoring and overall global drug development.

• In-depth knowledge of clinical development principles and concepts, including the regulatory landscape such as ICH GCP and relevant regional/local regulations.

• Experience in Oncology and/or Neurology and/or Immunology Therapeutic Areas is preferred.

• Significant (8+ years) experience in clinical operations within a CRO, pharmaceutical, or biotechnology company, encompassing site management/oversight and site-level clinical study execution.

• Excellent communication skills (verbal, written, and listening) in both native language and English.

• Ability to interpret and integrate site performance data for the prioritization of oversight activities.

• Knowledge of applicable T&E Policy requirements.

• The role necessitates domestic and international travel of up to 50% of the time.

• Capability to work independently on assigned tasks or projects of increasing complexity.

• Ability to engage in self-directed training, particularly on therapeutic areas, and synthesize key insights for studies under management.

• Typically operates without instruction on routine tasks, receiving only general guidance on new assignments.

• Strong negotiation skills with the ability to adapt to various stakeholders.

• Proven experience in vendor interactions.

• Strong critical thinking skills, with the ability to comprehend complex patient histories, medical terminology, and treatment landscapes in specific therapeutic areas.

• Detail-oriented, organized, and committed to maintaining quality and consistency.

• Results-oriented and adept at managing competing high-priority projects.

• Demonstrated success in meeting deliverables within established timelines.

• Adaptability to work in a dynamic environment requiring a high level of flexibility.

• Effective communication abilities with Key Opinion Leaders, site staff, and internal team members.

• Prior experience and proficiency in CTMS and eTMF systems is preferred.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.