The SDTL / Central Monitoring Manager works within the Risk Management Central Monitoring Group and leads clinical study teams in the study-specific design and implementation of Analytical Risk-Based Monitoring (ARBM) for clinical trials (Phase IIV).

In this role you will be responsible for a broad range of activities including:

• Risk identification and mitigation

• Data analysis and interpretation

• Leading cross-functional teams

• Multi-level communication with study team members

• Ongoing training on ARBM-related processes

• Participation in innovation and process improvement initiatives

Deliverables

GRAD (Level 0) / BASE (Level 1)

Services rendered will:

• Adhere to applicable Sponsor SOPs work instructions policies and local regulatory requirements.

• Support central study teams (including trial managers data managers study physicians study scientists quality colleagues and statisticians) in identifying critical study data processes and associated risks.

• Coordinate translation of identified risks and critical data/processes into risk mitigation and oversight plans including Quality Tolerance Limits (QTLs) to be followed during study execution.

• Support appropriate decision-making related to site management data review and contingency planning and provide input into study plans.

• Coordinate with cross-functional study teams to ensure compliance with established risk oversight plans and oversee site risk parameters.

• Conduct ongoing study and operational data reviews and follow findings through resolution including development of Site Mitigation Plans in collaboration with central and field teams.

This includes utilization of:

• Internal systems and databases

• External databases (as applicable)

• Custom report creation

• Data analysis and visualization tools

Followed by proper interpretation and investigation of risk indicators and trends. Additional responsibilities include:

• Supporting recurring cross-functional virtual study team meetings.

• Ensuring inspection readiness by maintaining complete accurate and timely data and essential documents in trial management systems (e.g. CTMS eTMF) in accordance with established metrics and archiving retention requirements.

• Participating in regulatory agency inspections and internal audits as required.

• Complying with relevant training requirements and maintaining therapeutic knowledge appropriate to assigned trials.

• Completing timely and accurate time reporting.

• Supporting a Primary CMM (Sponsor or provider) in a secondary capacity as applicable.

ADVANCED (Level 2)

Includes all responsibilities listed above with additional duties:

• Serve as Primary CMM in a leading capacity.

• Train and mentor GRAD/BASE-level CMMs.

• Organize and lead meetings.

• Document and distribute meeting minutes.

• Communicate effectively across stakeholders.

• Guide and influence colleagues in adopting new methodologies and processes.

Primary Interfaces

• Provider Functional Manager

• Sponsor Point of Contact (Central Monitoring Lead)

• Central Study Team

• Study Responsible Physician/Scientist

• Quality and Compliance Manager/Specialist

Education and Experience Requirements

Minimum Education

Bachelor of Science (B.S.) degree in one of the following or equivalent fields:

• Data Science

• Chemical Engineering

• Biomedical Engineering

• Materials Science & Engineering

• Polymer Science

• Microbiology

• Biotechnology

• Biological Sciences

• Chemistry

• Computer Science & Engineering

• Behavioral Science

Required knowledge:

• Solid understanding of data analytics

• Statistical concepts

• Data science principles

Preferred Education

Masters degree in one of the above scientific or related fields.

Experience Requirements

• Minimum 3 years of clinical trial experience (clinical operations data management statistics or related clinical development experience) within pharmaceutical medical device or CRO environments.

• Minimum one year of applied Risk-Based Central Monitoring experience (performing the duties of a Central Monitoring Manager) within pharmaceutical medical device or CRO environments.

• Demonstrated leadership in ARBM design and implementation.

• Strong analytical capability and mindset.

• Knowledge of ICH-GCP and drug development processes.

• Ability to operate and proactively use systems and databases (e.g. CTMS EDC systems KPI dashboards visualization tools) to analyze trial quality performance and compliance.

• Data analysis and technical skills related to clinical trials.

• Experience working with global and remote teams.

• Strong understanding of issue escalation and resolution principles.

• Advanced communication skills and ability to manage multiple communication streams.

• Ability to work with predefined common risks and adapt to protocol-specific risks.

• Team lead or functional management experience (preferred).

• Therapeutic area experience as required by assigned services.

• Strong working knowledge of ICH-GCP company SOPs local laws regulations assigned protocols and protocol-specific procedures.

• Proficiency in written and spoken English.

• Strong written and oral communication skills.

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IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.