Clinical Affairs Manager - Transfusion Medicine (Immunohematology/Blood Banking experience)

GRIFOLS, S.A.•San Diego, CA

58d•$131,764 - $164,000•Onsite

About The Position

Grifols Diagnostic Solutions in San Diego, CA is seeking a Clinical Affairs Manager. The Clinical Affairs Manager will execute clinical studies in accordance with IVD clinical guidelines, applicable regulatory requirements, company SOPs, and study protocols. He will participate in the management of budgets and timelines, as well as all the tasks of clinical study and ongoing process of improvement of clinical standard operation procedures, work instructions and tools. A Manager of Clinical Affairs works for all the IVD product lines, including Immunohematology, Immunoassay and NAT. This role will support local and international clinical studies. To succeed in this role, we are seeking individuals with at least a bachelor’s degree in science, Biomedical Science or health-related field or equivalent education/experience. Typically, the position requires 5 years’ experience in clinical research with at least 3 years of clinical trials execution role, preferably in an IVD company. Knowledge in Immunohematology and Immunoassay is preferred. If a master’s degree or PhD in Science, Biomedical Science or health-related field, equivalency is 2-4 years of IVD industry experience in clinical research.

Requirements

Bachelor's: Science, Biomedical Science or health-related field or equivalent education/experience
Typically requires 5 years’ experience in clinical research with at least 3 years of clinical trials execution role, preferably in an IVD company.
Experience in managing study teams, third parties, and other cross-functional personnel is required
If a master’s degree or PhD in Biomedical Science, equivalency is 2-4 years of IVD industry experience in clinical research.

Nice To Haves

Knowledge in Immunohematology and Immunoassay is preferred.

Responsibilities

Prepares and provides clinical status updates to the Clinical Affairs leadership team including timelines, budget, monitorization, deviation and corrective actions
Manages direct reports including performance evaluations and professional development
Manages internal and external training for clinical trials (Kick-off meeting, Investigator meeting, contract research organization (CRO) staff, Study site staff)
Effectively communicates study information to the Clinical Affairs team and other functional or departmental groups (R&D, Regulatory Affairs, PMOs). Works closely with all stakeholders in order to achieve the clinical study objectives. Actively participates in the statistical approach and framework for the IT systems to be used with the Clinical Data Team.
Works closely with the directors of Clinical Affairs in developing and contributing to the study budget, investigator budget template, including participation in and driving third party selection process
Monitor third party performance (e.g. study sites, referee labs, contract research organizations (CROs)) including on time study completion, budget adherence, and quality deliverables (Quality of data, mitigation resolution, corrective actions) and provide leadership with regular updates
Monitor activities of clinical sites. Ensure accurate, timely and complete monitoring of the results of the study. Ensure integrity of data and adequate mitigation plans are implemented if deviations are identified
Drafts documents including but not limited to clinical plan, study protocol, informed consent, site worksheets, study report, clinical documents for submission to regulatory agencies
Collaborates and provides solutions to difficult technical issues associated with the product and the clinical use that is run in the clinical study
Resolves escalated study conduct issues from study sites, regulatory authorities and IRBs/ECS or equivalent
Contributes to the identification of risks and opportunities (including contingency and mitigation plans)
Requests insurance certificates for clinical studies, reagents and instruments for clinical sites and all supplies needed for the clinical study
Monitors adherence to IVD clinical guidelines, applicable regulatory requirements, company SOPs and study protocols
Maintains all documents related to clinical studies including completing Trial Master File
Provides support in preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary (internal and external). Participates in meetings with regulatory agencies to discuss clinical studies.