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.
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.
Primary 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.
Education
Bachelor's: Science, Biomedical Science or health-related field or equivalent education/experience
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.
Equivalency:
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. Example: if a job level typically requires an associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree
Occupational Demands
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs tasks by following a set of written or oral instructions/procedures. Travel in the United States, occasional international travel.
Pay Scale
The estimated pay scale for this Clinical Affairs Manager role based in San Diego, CA, is $131,763.55 to $164,000 per year. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
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