Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The Manager, of Clinical Affairs, independently leads the planning and oversight of clinical development activities to support the validation of assigned essays. 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 Affairs 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 can be based in Raritan, NJ, or Rochester, NY. Remote work options will be considered.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 analyze 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 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.
Bachelor of Science required in medical, biological, or closely related science or medical specialty. Clinical Laboratory Scientist certification [MT/MLS (ASCP) or equivalent] preferred. Master's degree preferred. Blood Bank Specialist certification is a plus.
Minimum 2 years of donor screening testing experience required. Current knowledge of donor deferral, follow up and lookback procedures is a plus.
A 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.
Knowledge of regulations and standards (CFR, GCP, ICH, ISO, QSR, etc.) affecting IVDs and biologics is required.
Ability to deal with ambiguous situations, perform work effectively with a high degree of independent judgment without direct oversight with multi-level teams, and manages multiple projects and resources in a fast-paced and changing environment.
Ability to proactively identify and manage risks and issues (including mitigations and contingencies) to ensure cost-effective timely delivery of the project including escalation.
Maintain knowledge of the medical, biological, and technical/analytical aspects relevant to clinical programs.
Ability to provide critical thinking and leadership when issues arise during the execution of clinical studies.
Expertise in clinical data review and statistical analysis.
Demonstrated prior experience with strong client and vendor relationship management skills.
Demonstrated effective interpersonal, communication, and negotiation skills for a wide variety of audiences.
Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates.
Domestic and international travel up to 30% on an annual basis.
Key Working Relationships
Internal: Interacts with department personnel from Regulatory Affairs, Assay Product Development, Operations, Program Management, Customer Technical Support, Marketing, and Quality Assurance to align deliverables required for the conduct of clinical studies.
External: Interacts with key opinion leaders, clinical investigators, consultants, sample vendors, clinical research organizations, and other external service providers to obtain technical information, qualification assessments, or services necessary for the conduct of clinical and non-clinical studies.
Colorado State Posting Details: This position's starting salary is between $88,000 and $176,000 per year, and it is bonus eligible. Salary will be determined by the education, experience, knowledge, skills, and abilities of the candidate, in addition to internal equity and alignment with market data. Ortho offers a comprehensive benefits package, including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including paid sick time), and paid holidays. All benefits are non-contractual, and Ortho may amend, terminate, or enhance the benefits provided, as it deems appropriate.