Job Overview:

The Study Process Lead (SPL) oversees the execution of processes (structured, repeatable sets of deliverables related but not limited to eTMF support, EDC review, CTMS updates, Payment reconciliation, etc.) supporting clinical projects and research studies in accordance with global and local regulations.

SPLs collaborate closely with operational staff (CPCs/CPAs) and the management team (LMs) and serve as key members of a team of Centralized Administrative Services supporting a single Sponsor.

 Manages operational elements of processes supporting clinical projects to deliver contracted clinical services to client satisfaction by having ownership of the process and serving as point of contact (PoC) for client facing activities related to task planning, process updates, and any additional Ad-Hoc requirement.

Assures that all documentation complies with the expected quality, correct artifact, metadata, and location in accordance with customer internal conventions, SOPs, and WIs.

 Oversees, leads and assures the quality in the update of the clinical/regulatory databases such as CTMS, RDMS, and Clinical dashboards as per international guidance, GCPs, customer internal conventions, SOPs and WIs.

Manages and leads scheduled and ad-hoc payments reconciliations in accordance with customer internal conventions, SOPs and WIs.

 Manages and leads any additional activity identified within the scope of work of services provided to the client, fostering quality and compliance with GCPs and any applicable guidance, customer internal conventions, SOPs and WIs.

Essential Functions:

Includes but not limited to:

• Fully owns the assigned processes from process creation and continuously through process execution and improvement.

• To act as a leader of the tasks under assigned processes by:

• Ensuring correct scope definition, appropriate resourcing, and effective workforce organization.

• Performing close oversight of task progress and completion within the defined delivery deadlines.

• Providing CPC/CPA with ongoing support during task completion.

• Providing on demand training and creating relevant guidance materials for task completion.

• On-time escalation to LM team of performance issues and/or deliveries at risk.

• Effectively communicates with the Client, other SPLs, CPCs/CPAs and the LM team on process performance, escalations, identified issues, process improvement proposals, etc.

• Assists the Client in effective management and oversight of activities including but not limited to:

• eTMF management, such as document filing, post-approval QC review, etc.

• Regulatory documentation filing.

• Creation of Safety Letter packages for site activation.

• Compilation of PD Listings and filing in eTMF.

• Creation of CSR Appendices.

• Reconciliation of payments at different levels and timeframes.

• Access management for external users to Client’s SharePoint.

• Any additional activity identified and previously approved by the Client to be within Scope of Work.

Minimum requirements for Study Process Lead (G130)/Sr. Study Process Lead (G140):

• Minimum 3-4 years of experience (4-5 years for Sr. Study Process Lead) in the clinical trial industry (previous CRO employment).

• Excellent command of English language.

• Excellent command of Microsoft Office.

• Working knowledge of Project Management principles (In-depth knowledge required for Sr. Study Process Lead) – Planning, Resourcing, Execution, Oversight, Risk Management (any completed Project Management Fundamentals course is a plus).

• At least 2 years of experience (3 years for Sr. Study Process Lead) with Clinical Trial Management systems (CTMS) and/or eTMF (preferably Veeva Vault eTMF).

• Preferably with previous experience as Senior Clinical Trial Assistant / Project Support Coordinator / Senior eTMF File reviewer, or Project Management Analyst / Project Support Coordinator with minimum 1 year of experience in the role.

• Experience with EDC (Medidata), Regulatory Management systems, and Contract Management systems is a plus.

• Experience as Subject Matter Expert (SME) and/or Trainer and/or Mentor is a plus.

• Experience in client facing role is a plus.

• Experience with advanced Excel features is a plus (Macros, Analytics).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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.