Associate Clinical Research Manager, Immunology, Remote

About the role

With support of other Clinical Research Managers (CRMs) and/or Therapeutic Area Head (TAH) / Clinical Research Director (CRD), this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH-GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Associate Clinical Research Manager (aCRM) could be responsible for a particular study for a country or a cluster.

Responsibilities

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate Manager (CRAM) and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinators (CTC), Clinical Research Associates (CRAs) and Clinical Operations Managers (COMs).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA-Head/CRD/Country Clinical Quality Manager (CCQM) and or CTT (as appropriate).
• Identifies and shares best practices.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• As a customer-facing role, this position will build business relationships and represent our company with investigators.
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head and Regional Operations.
• Collaborates internally with Headquarters (HQ) functions, regional and local operations, European Union (EU) Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.

Qualifications & Experience

• Bachelor's degree in science (or comparable).
• 4+ years of experience in clinical research.
• CRA experience preferred.
• Immunology experience preferred.

Required Skills

• Adaptability
• Clinical Research
• Clinical Trials Operations
• Critical Thinking
• Decision Making
• External Partners
• Good Clinical Practice (GCP)
• ICH GCP Guidelines
• Project Management
• Quality Management
• Regulatory Compliance
• Risk Management
• Strategic Planning
• Verbal Communications

Preferred Skills

• Clinical Study Management
• Cross-Cultural Awareness
• Deliverables Management
• Immunology
• Relationship Building

Pay & Benefits

The salary range for this role is $117,000.00 - $184,200.00. 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. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. Available benefits include 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.

Schedule & Travel

Remote with up to 30% travel. This is a regular, full-time position with a 1st shift schedule. Visa sponsorship is not available and relocation is not offered.