Clinical Research Manager (CRM) Lead - Lung

This role will be key to further develop the country capabilities in clinical research. Under the direction of the country or cluster CRD/TA-Head, the person will be responsible for the end-to-end performance of clinical trials in one or several Therapeutic Areas (TA), from feasibility to close out in one or several countries.

Responsibilities

• Lead one or several Therapeutic Areas (TA) of the growing portfolio in the country.
• Accountable for the successful execution, enrollment, and quality of their clinical trial portfolio.
• Ensure performance metrics, timelines, and key milestones are met in compliance with ICH/GCP, country regulations, company policies and procedures, quality standards, and adverse event reporting requirements.
• Develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio.
• Collaborate with other TA directors, local and regional stakeholders in GCTO to develop and build territory of principal investigators and sites.
• Ensure oversight and line management of the Clinical Research Manager (CRM) team.
• Oversee the performance management and career development of staff, effectively manage performance issues, and lead a team independently with supervision from CRD/TAH to high performance.
• Accountable for CRM performance reviews, addressing low performance situations, and taking appropriate actions.
• Ensure key talent development and retention.
• Collaborate internally with cross-functional teams on local, regional, and global levels.
• Collaborate externally with investigators, regulators, and vendors.
• Support strategic initiatives across country, Global Clinical Development (GCD), and GCTO.
• Support local strategy development consistent with long-term corporate needs in conjunction with CRD.
• Contribute significantly to the effective conduct of clinical studies and pipeline development while maintaining regulatory requirements and compliance.
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
• Responsible for project management of assigned studies: proactively plan, drive, and track execution and performance of deliverables/timelines/results to meet country commitments from feasibility, site selection, recruitment, execution, and close out.
• Review Monitoring Visits Reports and escalate performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.
• Perform Quality Control visits as required.
• Lead local study teams to high performance: train in the protocol other local roles, closely collaborate with and support CRAs as protocol expert, and coordinate activities across different local country roles ensuring strong collaboration.
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensure compliance with CTMS, eTMF, and other key systems in assigned studies.
• Escalate challenges and issues to TA-Head/CRD/CCQM and/or CTT as appropriate.
• Identify and share best practices across clinical trials, countries, and clusters.
• Act as a mentor.
• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Build business relationships and represent the company with investigators and medical centers.
• Serve local business needs (if delegated, can sign contracts and manage budgets).
• Support local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head, and Regional Operations.

Requirements

• 10+ years of experience in clinical research with demonstrated success and increasing responsibilities, of which 5+ years consisted of leading projects and teams.
• Bachelor's degree in Science (or comparable).
• Expertise in project and site management, with demonstrated successful implementation of project management skills at program and site level.
• Strong organizational skills with demonstrated success.
• Ability to make decisions independently and oversee important activities relevant to clinical research according to predetermined global policies and commitments.
• Complete understanding of ICH GCP and global/regional/local regulatory environment.
• Strong scientific and clinical research knowledge, including extensive knowledge of regional and/or country clinical trial landscape.
• Deep understanding of the Research and Development division organizational structure and cross-functional roles and responsibilities.
• Strong understanding of clinical trial planning, management, and metrics, with the ability to focus on multiple deliverables and execute complex protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Ability to communicate effectively and foster a collaborative spirit in a remote/virtual environment and across countries, cultures, and functions.
• Proven ability to proactively manage resource allocation, processes (and controls), productivity, quality, and project/program delivery.
• Oversee TA strategy alignment and consolidate relevant information within specific indications, escalating to the TA-H/CRD accordingly.
• Proficiency in written and spoken English and local language.
• Strategic thinking and ability to work efficiently in a remote and virtual environment.
• Proven strong project management skills and/or project management certification or relevant training program/close mentoring.
• High emotional intelligence and ability to focus on multiple deliverables and protocols/projects simultaneously.
• Exercise strategic thinking and execute effectively across projects.
• Cultivate intercultural understanding.
• Strong leadership skills that enable and drive alignment with the goals, purpose, and mission of the Research and Development division, Global Clinical Development (GCD), and GCTO.
• Ability to identify problems, conflicts, and opportunities early, lead analysis, creatively prepare mitigation plans, and drive conflict resolution.
• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption.
• Educational/pedagogic, diplomatic, and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Qualifications

• Preferred CRA experience.
• Lung experience preferred.
• Advanced degree (e.g., Master’s degree, MD, PhD).

Skills

• Clinical Trial Management
• Clinical Trials Operations
• Cross-Cultural Awareness
• Oncology Trials
• People Leadership

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Annual bonus and long-term incentive (if applicable).

Pay

The salary range for this role is $142,400.00 - $224,100.00. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Schedule

Extent of travel: up to 30% of working time.