Associate Clinical Country and Site Lead – West Coast, Midwest

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

📋 Description

• Assist the Clinical Country and Site Lead by offering local operational and scientific insights to global teams.

• Incorporate local opportunities and requirements into clinical operational strategies.

• Act as the primary country-level contact for CRO personnel and QSDO/global teams.

• Facilitate the execution of local clinical trials with an emphasis on quality, patient safety, and monitoring oversight.

• Address investigator concerns regarding data integrity, patient safety, or unresolved issues with CROs.

• Stay informed about local clinical knowledge, disease areas, standards of care, and the needs of clinicians conducting trials.

• Deliver country-specific therapeutic-area, disease-area, program, and study information to aid global operational strategy.

• Coordinate contributions from local affiliates into the Clinical Development Plan.

• Manage relationships and knowledge sharing with investigators and sites.

• Develop or implement strategies for engaging investigators.

• Lead or assist in local activities related to country and site selection.

• Facilitate timely communication and issue resolution among investigators, affiliate staff, CRO/FSP personnel, and global teams.

• Analyze and track country performance KPIs while supporting operational milestones.

• Contribute to special projects and other QSDO initiatives as a CSO or Country representative.

⛳️ Requirements

• A Bachelor’s degree or equivalent is required.

• A minimum of 5 years of clinical research experience, particularly in managing clinical trial activities, especially in an outsourced/FSP model.

• Familiarity with cross-functional drug development processes.

• Comprehensive scientific/clinical knowledge across major therapeutic areas.

• Understanding of ICH/GCP, relevant country regulations, and clinical trial monitoring in an outsourced environment.

• Strong organizational and project management capabilities.

• Ability to define clear objectives, prioritize tasks, and manage multiple activities effectively.

• Proficient in relevant IT tools for efficient virtual teamwork.

• Extensive knowledge of clinical operational activities and associated challenges within the local geography.

• Demonstrated ability to manage a high volume of tasks with varying complexities and priorities.

• Excellent communication skills.

• Proficiency in English in regions where it is not the primary language.

• Capability to quickly assimilate new knowledge.

• Willingness to travel up to 80% (approximately once a week).

• Preferred: experience in fully outsourced and Functional Service Provider (FSP) models.

🏝️ Benefits

• Medical, Dental, Vision, & Life insurance coverage.

• Fitness & Wellness programs, including fitness reimbursement.

• Short- and Long-Term Disability insurance.

• A minimum of 15 paid vacation days.

• Additional time off for end-of-year shutdown (Dec 26-Dec 31).

• Up to 12 paid company holidays plus 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Access to Employee Resource Groups.

• Short-term and long-term incentives, including cash bonuses and equity opportunities.