Manager, Clinical Trials

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Manages clinical trial studies for specific therapeutic area(s).  Provides guidance and oversight to internal and external project team members for the successful management of all aspects of study operation management in accordance with GCP/ICH Guidelines, applicable regulatory requirements, company SOPs, and study protocols.      

 

Primary Responsibilities:

• Manages direct reports including performance evaluations and professional development.
• Oversees third party vendors as well as develops and coordinates responses to third party vendor audits.
• Evaluates vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate.
• Provides clinical input and/or develops required clinical documents for submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports), as necessary.
• Manages overall planning of investigator meetings.
• Develops study specific timelines and manages/mitigates with program timelines.
• Ensures internal functional areas drive to completion of deliverables to manage study issues and support milestone achievement.
• Oversees that study information is effectively communicated to data management, safety, regulatory personnel, and other functional or departmental groups.
• Contributes to study specific clinical risks and opportunities registry for studies assigned including identification of risks, opportunities, contingency and mitigation plans.
• Partners with Biometry to develop robust case report forms, data management plan, data transfer plans, data cleaning, data reconciliation and coordinate clinical review of listings.
• Partners with Manager of Supplies to ensure timely manufacturing, packaging, labeling, and shipping of supplies are created according to regulatory/country specifications in required timeline.
• Works closely with Manager of Contracts in developing and contributing to the study budget, RFPs and Investigator budget template, including participation in and driving the vendor selection process.
• Manages and leads meetings with CROs, vendors, and multi-functional teams on a day-to-day basis to ensure quality, on budget and timeliness of deliverables.
• Reviews site and vendor invoices to ensure that project expenses are in accordance with work conducted.
• Ensures appropriate training is conducted for internal staff, CRO staff, vendors, investigators, and study coordinators on study requirements, therapeutic indication and SOPs.
• Maintains overall responsibility for ensuring the resolution of escalated study conduct issues from study centers, regulatory authorities and IRBs/ECs.
• Reviews escalated issues from study managers and CRAs to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and site audit report findings).
• Drafts, reviews and approves relevant documents including informed consent, site worksheets, vendor site manuals, pharmacy manual, and central laboratory manual, as necessary.
• Oversees CTMS tracking that supports evaluation and continual management of clinical study set-up and follow-up study activities.
• Monitors adherence to the regulatory/essential document collection process and release of clinical supplies.
• Manages the trial master file process including ongoing maintenance, accurate filing and administration of QC plan.
• Reviews tables, listings, and EDC data to ensure integrity of data and identify trends.

 

Knowledge, Skills, & Abilities:

Good strategic thinking skills that enables proactive planning.  Good verbal, written, and interpersonal skills.  Good motivational, decisive decision-making and issue resolution skills.  Good ability to prioritize and effectively manage changing priorities.

 

Requirements:

• Bachelor's degree
• Typically requires 5 years experience in clinical research with clinical trials management / leadership role preferably in a pharmaceutical company.  Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel. Project or technical leadership experience required.  Supervisory or ma