Clinical Research Manager, Immunology, Remote

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP) and country regulations, our Company policies and procedures, quality standards, and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in 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, our 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 (CRA) Manager 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 Clinical Research Associates (CRAs) as protocol expert, and coordinates activities across the different local country roles ensuring strong collaboration (including the Clinical Trial Coordinator (CTC), CRAs, and Clinical Operations Manager (COM)).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), and other key systems in assigned studies.
• Escalates challenges and issues to Therapeutic Area (TA) Head/Clinical Research Director (CRD)/Country Clinical Quality Manager (CCQM) and/or CTT (as appropriate).
• Identifies and shares best practices across clinical trials, countries, and clusters.
• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• Builds business relationships and represents our Company with investigators as a customer-facing role.
• Serves local business needs as applicable in his/her country (if delegated, can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, Therapeutic Area Head (TAH), and Regional Operations.
• Collaborates internally with Headquarters (HQ) functions, regional and local operations, European Union (EU) Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consults with Global Human Health (GHH) as needed.

Requirements

• 5+ years of experience in clinical research.
• Bachelor’s degree in science (or comparable).
• Proficiency in written and spoken English and local language.
• Strong organizational skills with demonstrated success.
• Ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments.
• Strong understanding of local regulatory environment.
• Strong scientific and clinical research knowledge.
• Strong understanding of clinical trial planning, management, and metrics, as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Ability to communicate effectively and build collaboration in a remote/virtual environment across countries, cultures, and functions.
• Skills to manage resource allocation, processes (and controls), productivity, quality, and project delivery.
• Strategic thinking and ability to work efficiently in a remote and virtual environment.
• Understanding of cultural inclusion.
• Proven strong project management skills and/or project management certification or relevant training program/close mentoring.

Preferred Qualifications

• Clinical Research Associate (CRA) experience.
• Immunology experience.
• Trial management experience.
• Advanced degree (e.g., Master’s degree, MD, PhD).

Skills

• Adaptability
• Clinical Research
• Clinical Trials Operations
• Decision Making
• Good Clinical Practice (GCP)
• Quality Management
• Regulatory Submissions
• Risk Management
• Strategic Planning
• Strategic Thinking

• Preferred Skills:
• Clinical Study Management
• Deliverables Management
• Immunology
• Leadership
• Peer Mentoring

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

• Up to 30% travel of working time.
• Flexible work arrangements: Remote.
• Shift: 1st - Day.