Clinical Development Operations Lead

Baylor Genetics; Kentucky; Hybride; USD 60 000 - 90 000; Plein temps

Résumé du poste

Baylor Genetics in Kentucky is seeking a Clinical Development Coordinator to act as the central operational hub for the Clinical Development team, coordinating study activities, timelines, meetings, and cross-functional communication.

You will organize workflows, maintain trackers and dashboards, prepare meeting materials, and ensure timely follow-through with internal and external partners while keeping documentation audit-ready and compliant.

Qualifications

• Degree in Life Sciences or related field as listed in the job requirements.
• Strong organizational, documentation, meeting coordination, and project tracking skills.
• Excellent oral and written communication skills.
• Ability to manage multiple priorities in a deadline-driven environment.
• Experience coordinating activities across multiple stakeholders and functional teams.

Responsabilités

• Serve as the central coordinator for Clinical Development team activities, including project plans, timelines, meeting schedules, deliverables, action-item tracking, follow-up reminders, and risk or delay escalation.
• Support clinical studies, evidence-generation initiatives, registries, and strategic collaborations by coordinating study-related activities, maintaining trackers, organizing project documentation, preparing meeting materials, and ensuring stakeholders have the information needed to complete assigned tasks.
• Facilitate day-to-day coordination among cross-functional teams by routing information, clarifying next steps, and supporting timely cross-functional communication.
• Prepare and distribute project dashboards, status reports, presentations, meeting agendas, meeting minutes, decision logs, and leadership updates to support team alignment and visibility.
• Maintain organized documentation repositories and ensure development records, project files, trackers, meeting notes, and study documentation are complete, accurate, current, and audit-ready.

Connaissances

Attention to Detail

Analytical Thinking

Oral and Written Communication

Teamwork and Collaboration

Follow-through and Accountability

Initiative

Formation

Bachelor's degree in Life Sciences, Genetics, Molecular Biology, Public Health, Healthcare Administration, Clinical Research, or related field

Master's degree or PhD

Outils

Excel

Word

PowerPoint

Outlook

Teams

SharePoint

Description du poste

Baylor Genetics, a leader in clinical genomics and precision medicine, is seeking a highly organized and collaborative Clinical Development Coordinator to serve as the central coordination point for the Clinical Development team. This role supports the day-to-day execution of clinical development activities across genomic testing, rare disease, precision medicine, and evidence-generation programs by organizing workflows, maintaining timelines, tracking action items, coordinating meetings, and facilitating communication across stakeholders.

As the operational hub for the team, the Clinical Development Coordinator helps keep projects, documentation, meetings, communications, and follow-ups organized and moving forward. The Coordinator works closely with internal cross-functional teams, external collaborators, clinical investigators, healthcare institutions, and strategic partners to ensure that key activities are tracked, deadlines are visible, decisions are documented, and appropriate follow-through occurs.

The ideal candidate is detail-oriented, proactive, service-minded, scientifically literate, and comfortable coordinating multiple workstreams without being the primary strategic owner of each initiative.

KEY RESPONSIBILITIES

• 35%: Serve as the central coordinator for Clinical Development team activities, including project plans, timelines, meeting schedules, deliverables, action-item tracking, follow-up reminders, and risk or delay escalation.

• 25%: Support clinical studies, evidence-generation initiatives, registries, and strategic collaborations by coordinating study-related activities, maintaining trackers, organizing project documentation, preparing meeting materials, and ensuring stakeholders have the information needed to complete assigned tasks.

• 20%: Facilitate day-to-day coordination among Clinical Development, Medical Affairs, Regulatory Affairs, Laboratory Operations, Research & Development, Bioinformatics, Quality, Commercial, and external partners by routing information, clarifying next steps, and supporting timely cross-functional communication.

• 10%: Prepare and distribute project dashboards, status reports, presentations, meeting agendas, meeting minutes, decision logs, and leadership updates to support team alignment and visibility.

• 10%: Maintain organized documentation repositories and ensure development records, project files, trackers, meeting notes, and study documentation are complete, accurate, current, and audit-ready.

• Perform other duties as assigned to support team and organizational objectives.

• Comply with all company policies, procedures, and applicable regulatory requirements.

QUALIFICATIONS

Required

• Degree: Bachelor's degree in Life Sciences, Genetics, Molecular Biology, Public Health, Healthcare Administration, Clinical Research, or related field.

• Minimum 2 years of experience in clinical research, clinical operations, clinical development, project coordination, biotechnology, diagnostics, pharmaceutical development, healthcare, or related fields.

• Demonstrated ability to manage multiple priorities in a deadline-driven environment.

• Experience coordinating activities across multiple stakeholders and functional teams, including tracking follow-ups and helping maintain team alignment.

• Strong organizational, documentation, meeting coordination, and project tracking skills.

• Excellent oral and written communication skills.

• Strong attention to detail and ability to follow processes consistently.

• Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, Outlook, Teams, and SharePoint.

• Equivalent combination of education and experience may be considered.

Preferred:

• Master's degree or PhD.

• Experience supporting clinical trials, registries, observational studies, or evidence-generation programs.

• Familiarity with GCP, clinical study documentation, regulatory processes, or healthcare compliance environments.

• Experience working with CROs, academic medical centers, healthcare systems, or industry partners.

• Exposure to genomics, molecular diagnostics, rare disease, precision medicine, or laboratory-developed testing.

• Experience with project management platforms such as Smartsheet, Microsoft Project, Monday.com, Asana, or Jira.

COMPETENCIES

• Attention to Detail

• Analytical Thinking

• Oral and Written Communication

• Teamwork and Collaboration

• Follow-through and Accountability

• Initiative and Accountability

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• Frequently required to sit and utilize a computer workstation.

• Frequently required to communicate verbally and in writing with internal and external stakeholders.

• Frequently required to review technical, scientific, operational, and regulatory documentation.

• Frequently required to participate in virtual and in-person meetings.

• May require occasional travel to conferences, partner sites, healthcare institutions, or company meetings.

EEO STATEMENT

Baylor Genetics is proud to be an equal opportunity employer committed to fostering an inclusive and diverse workplace. We welcome and encourage applicants from all backgrounds to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, pregnancy, childbirth, or any other status protected by applicable federal, state, or local law. If you need an accommodation during the application process, please contact our Human Resources team.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.