Grifols · 2 days ago
Clinical Study Manager
North Carolina, United States
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expGrifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. The Clinical Study Manager provides guidance and oversight to project team members for the successful management of all aspects of study operations in accordance with regulatory requirements and company SOPs.
BiotechnologyHealth CareManufacturing
Responsibilities
Monitors adherence to the regulatory/essential document collection process and release of clinical supplies
Coordinates training of CRO staff, vendors, investigators, and study coordinators on study requirements and SOPs
Assists in evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serves in key role to develop/implement corrective action plans as appropriate
Resolves escalated study conduct issues and provides clinical responses to questions from study centers and institutional review boards/ethics committees
Reviews escalated issues from CRAs to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and/or site audit report findings)
Ensures responses to site audits are adequately managed by designated clinical staff
Provides assistance in the management of the trial master file process, including ongoing maintenance, accurate filing and administration of quality control (QC) plan
Provides oversight of CTMS tracking to support evaluation and continual management of clinical study set-up and follow-up study activities, as needed
Reviews site invoices to ensure that clinical expenses are in accordance with work conducted
Drafts, reviews and approves relevant documents, including informed consent, site worksheets, vendor site manuals (pharmacy, lab), and monitoring reports
Oversees integrity of clinical data to ensure data meets GCP standards, including identification of trends reported from vendors and via review of study data
Assists in the planning and coordination of investigator meetings, as necessary
Provides clinical input in the development of case report forms, data management plan, and data listings review
Participates in vendor selection and contributes to the RFP process
Provides input for site, study and/or vendor specific budgets, as needed
Contributes to the identification of risks and opportunities (including contingency and mitigation plans) for the clinical risks and opportunities registry
Prepares key reports on study progress and assists in delegated clinical study management responsibilities
Tracks and assists in the development of study specific timelines, including management and mitigation of deliverables
Serves as contact for interacting with and conveying study information to data management, safety, regulatory personnel, and other functional or departmental groups, as necessary
Leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables, as necessary
Qualification
Required
Bachelor's degree
Typically requires 8 years of experience in clinical research, including 2 years in a study management/leadership role
Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
Company data provided by crunchbase