Associate Clinical Research Manager (aCRM) - Infectious Disease/Vaccine

About the Role

With support of other CRMs and/or TA-Head/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 aCRM may 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, and results to meet country commitments from feasibility and site selection through 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 Visit Reports and escalates performance issues and training needs to 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 other local roles in the protocol, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles ensuring strong collaboration (including CTCs, CRAs, and COMs).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
• Escalates challenges and issues to TA-Head/CRD/CCQM and/or CTT as appropriate.
• Identifies and shares best practices.
• Responsible for collaboration with functional outsourcing vendors, investigators, and other external partners in assigned studies.
• As a customer-facing role, builds business relationships and represents the 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 HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, and Global Medical and Scientific Affairs to align on key issues and decisions across the trials.
• Consults with Human Health as needed.

Extent of Travel

Up to 30% of working time.

Qualifications

• Bachelor's degree in science (or comparable).
• 4+ years of experience in clinical research.
• CRA experience preferred.
• Vaccine/Infectious Disease experience preferred.
• Knowledge in Project Management and/or site management.
• Strong organizational skills with demonstrated success in a related role or discipline.
• Ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments, with the support, oversight, and supervision of the TA-Head or CRD.
• Understanding of the local regulatory environment.
• Scientific and clinical research knowledge required.
• Understanding of clinical trial planning, management, and metrics, with the ability to focus on multiple deliverables and protocols simultaneously.
• Ability to function as a key link between Country Operations and Clinical Trial Teams.
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.
• Ability to manage processes (and controls), productivity, quality, and project delivery.
• Proficiency in written and spoken English and local language; competent and effective in written and verbal communication.
• Strategic thinking.
• Ability to work efficiently in a remote and virtual environment.
• Aptitude for building leadership skills that enable and drive alignment with the goals, purpose, and mission of the company, Global Clinical Development (GCD), and GCTO.
• Ability to identify problems, conflicts, and opportunities early; analyze and prepare mitigation plans; and drive conflict resolution.
• Required to negotiate skillfully in tough situations with both internal and external groups and settle differences with minimum disruption. Examples include: low patient recruitment, inadequate staff to meet business needs, performance or compliance issues, and resolution of conflictive situations.
• Strong diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Required Skills

Clinical Research, Clinical Site Management, Clinical Trial Compliance, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, ICH GCP Guidelines, Negotiation, Patient Recruitment, Process Management, Project Management Methodology (PMM), Regulatory Compliance, Regulatory Frameworks, Risk Avoidance, Site Selections, Stakeholder Negotiations.

Pay

The salary range for this role is $117,000.00 – $184,200.00. This is the lowest to highest salary the company in good faith believes it would pay for this role at the time of posting. An employee's position within the salary range is based on 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.

Benefits

A comprehensive package of benefits is offered. 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.