Manager, Clinical Operations

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Manager, Clinical operations in the Clinical Affairs department. The Manager, Clinical Operations under the supervision of the Director of Clinical Affairs, leads the planning and oversight of clinical development activities to support the validation of assigned assays. This position is responsible for interpreting medical, scientific, and clinical strategy and driving clinical development and study management of multiple moderate to highly complex clinical programs including, but not limited to, the planning, implementation, oversight, project management and completion of clinical studies conducted by Clinical Affairs or Contract Research Organizations (CRO). The Manager, Clinical Operations serves as a subject matter expert for clinical studies and serves as a mentor for Clinical Affairs staff. He/she will drive results through inspired leadership with a focused and disciplined approach to clinical development that is consistent with best practices in the industry. 

This position is remote eligible and will require flexibility in time zone coverage.

The Responsibilities

• Independently plans and executes clinical studies and leads cross-functional teams responsible for the planning, execution, analysis and reporting of assigned clinical performance studies. Applies expertise in clinical data review and statistical analysis. Reviews and approves clinical designs, protocols, and summary reports. Ensures that assigned Clinical Affairs staff and contractors have appropriate knowledge of relevant analyzer and assay technologies. Represents Clinical Affairs in cross-functional Program Management Teams.
• Independently develops and presents program strategies to ensure that the clinical programs effectively achieve the overall assay product development program objectives within approved budgets and committed timelines and in compliance with all relevant laws, regulations, guidelines, and internal policies & SOPs. When necessary, presents and defends clinical study designs, procedures, and data analysis to regulatory authorities. Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path, and other key deliverables including efficiency and effectiveness of plans and staff.
• Evaluates and statistically analyzes data that is clinically/scientifically sound to confirm or deny performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements. Authors clinical summary reports and technical documents and summarizes clinical performance data for product labeling. Contributes to the authoring of presentations and publications of clinical study data
• Identifies, qualifies, selects, and manages external service providers responsible for multi-million-dollar budgets. Responsible for management of vendor performance to ensure adherence to scope of work within timelines and budget at a task level. Proactively assesses potential risks to the study and proposes mitigation plans
• Provides cost and staffing estimates for clinical projects, ensuring appropriate input from the functional teams responsible for the conduct of assigned studies. Participates in establishing and tracking of assigned study budgets and staffing plans in the BERT system. Hire, train and evaluate staff.
• Participates in the development and maintenance of SOPs and/or initiatives and departmental coaching/ mentoring for the development of clinical personnel.
• Supports company cross-functional strategic business integration and process improvement initiatives and special projects.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor of Science required in medical, biological, or closely related science or medical specialty or minimum 10 years’ experience in a science or medical field Clinical Laboratory Scientist certification [MT/MLS (ASCP) or equivalent] preferred.
• Minimum 7 years of clinical study experience, (e.g., IVD, pharmaceutical, medical device, CRO) required.
• Minimum of 2 years of IVD clinical study experience including the proven ability to oversee clinical teams in the conduct and report of multicenter, complex studies is required.
• At least 2 years of demonstrated individual/team supervisory and management experience is required; budgetary experience is preferred.
• Ability to travel 25-30% annually.
• This position is not currently eligible for visa sponsorship. 

Internal Partners:

• Across all levels of the organization

External Partners:

• Customers, clients and vendors.

The Work Environment

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. 25-30% travel required. Travel includes airplane, automobile travel and overnight hotel.

Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials. 25-30% travel required, including domestic and global. Travel includes airplane, automobile travel and overnight hotel.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $120,000 to $140,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.