Clinical Affairs Senior Manager

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.

Clinical Affairs Senior Manager

Summary:

The Clinical Affairs Senior Manager will be a hands on position with future leadership opportunity, based at our San Diego Campus and working for all of our IVD product lines, including Immunohematology, Immunoassay and NAT. The position has the opportunity to work in multiple clinical studies in USA, EU and China. The main responsibility will be overseeing and guiding internal and external project teams for the successful management of all aspects of clinical study management in accordance with IVD clinical guidelines, applicable regulatory requirements, company SOPs, and study protocols. The Senior Manager reports directly to the Director of Clinical Affairs and will work closely with other groups like R&D, Regulatory Affairs, PMOs. Working knowledge of the appropriate analytical techniques in the field of IVD is a must to be able to fulfill the role as well as first experience in clinical trials management. The ability to manage cross functional teams, outstanding communication and project management skills will help the Sr. Manager to succeed. The Senior Manager of Clinical Affairs will be a hand on role, who will participate in the management of budgets and timelines, as well as all the tasks of multiple clinical study and ongoing process of improvement of clinical standard operation procedures, work instructions and tools.

Why Grifols:

The Sr. Manager will be part of building our international Clinical Affairs Team, is a decision maker & creator and is given the opportunity to grow and work in international projects. The work environment is characterized by an open leadership style and an open and supportive culture.

Your primary responsibilities:

• You participate in the preparation of clinical status updates (Timelines, budget, monitorization, deviation, corrective actions…)
• In the future you manage direct reports, this includes performance evaluations and professional development
• You provide and manage internal and external training for clinical trials (Kick-off meeting, Investigator meeting, contract research organization (CRO) staff, Study site staff)
• You oversee that study information is effectively communicated to the Clinical Affairs team and other groups by leading and managing meetings.
• You align the statistical approach and framework for the IT systems to be used with the Clinical Data Team and you ensure that the product is ready for a difficult clinical study from a Technical and Regulatory point of view.
• You work closely with the Director of Clinical Affairs in developing and contributing to the study and investigator budget, you also participate in driving third party selection processes
• You oversee third party performance (e.g. study sites, referee labs, contract research organizations (CROs)). This includes on time study completion, budget adherence, and quality deliverables (Quality of data, mitigation resolution, corrective actions...)
• You monitor and manage monitoring activities of clinical sites to ensure accurate, timely and complete monitoring of the results of the study. You also ensure integrity of data and adequate mitigation plans are implemented if deviations are identified
• You draft, review and approve documents like clinical plan, study protocol, informed consent, site worksheets, study report, clinical documents for submission to regulatory agencies
• You provide solutions to difficult technical issues associated to the product and the clinical use that is run in the clinical study
• You maintain overall responsibility for ensuring the resolution of escalated study conduct issues from study sites, regulatory authorities and IRBs/Ecs or equivalent
• Ou contribute to the identification of risks and opportunities (including contingency and mitigation plans) for the clinical risks and opportunities registry
• You request insurance certificates for clinical studies, reagents, and instruments for clinical sites
• You monitor adherence to IVD clinical guidelines, applicable regulatory requirements, company SOPs and study protocols
• You provide support to preparation of site inspections, attends site inspections, and support responses to site inspections, as necessary (internal and external). You participate in meeting with regulatory agencies to discuss clinical studies

More about us, benefits we provide you

• salary in line with the market as well as an annual bonus target see PayScale below)
• flexible working hours
• free parking
• Paid sick leave, paid Vacation, paid holidays including two flex holidays
• Professional development opportunities (training, career development)
• Gym pass, Employees perks program
• 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)
• Health insurance: Medical, Dental, Vision
• Travel accident insurance; Life and AD and D Insurance, Short- & Long-Term Disability Insurance
• Health Savings Account, Flexible Spending Account
• Critical Illness, Accident, Hospital Indemnity coverages
• Adoption benefits
• Pet insurance

About you:

Knowledge, Skills, and Abilities we are looking for

• working knowlage of the appropriate analytical techniques is required (IVD)
• Strong strategic thinking skills that enables proactive planning. 
• Strong verbal, written, and interpersonal skills when dealing with internal and external stakeholders. 
• Strong motivational, decisive decision making and issue resolution skills.
• Strong ability to prioritize and effectively manage changing priorities.
• Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Work independently and collaborative
• Ability to apply abstract principles to solve complex conceptual issues.
• Ability to work in a fast pace environment with competing priorities.
• Strong demonstrated negotiation and conflict resolution skills both internal and external
• Working knowledge of cGMP/GLP, proficiency in Microsoft Office, basic Change Control
• Manufacturing experience in blood components manufacturing preferred
• Development and Problem-Solving experience in blood processing is preferred 
• Ability to communicate with cross-functional partners effectively and actively (e.g., Supply Chain, Manufacturing Sciences, Warehouse)
• Ability to train personnel effectively
• Good organizational skills and strong attention to detail
• Team oriented, attentive, and willing to learn new processes
• Demonstrated technical writing skills
• Ability to write, review, mark-up, and format documents in Word
• Demonstrated ability to multitask, prioritize and complete goals
• Demonstrated sound technical knowledge and good independent judgement

Education and Experience we require for this role

• Requires a bachelor’s degree of Biomedical Science or equivalent degree
• Typically, 12 years in clinical research with a bachelor’s degree, 10 years if you have a Master's degree
• 3+ year clinical trials management / leadership role preferably in an IVD company experience (If Master’s degree or PhD in biomedical science, equivalency is 2-4 years of IVD industry experience in clinical research)
• Advanced leadership and clinical trial/project management experience in managing study teams, third parties, and other cross-functional personnel

Equivalency

Depending on 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 requires a bachelor’s degree plus 4 years of experience, an equivalence could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Masters’ degree with 2 years of experience.

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. Frequently drives to site locations with travel within the United States and occasional internationally.

Pay Scale

Pay scale of $145,000 - 181,000/year, depending on training, education, and experience.  This position is eligible to participate in up to 15% of the company bonus pool.  We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

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Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg 

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