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Job title: Manager, Clinical Science- Remote
Company: Ortho Clinical Diagnostics
Job description: The Career Potential
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 Opportunity
As we continue to grow, we are seeking a Manager, Clinical Science in the Clinical Operations department. The Manager, Clinical Science under the supervision of the Director, Global Clinical Operations, uses strong technical expertise and scientific principles to identify clinical opportunities that maximize commercial value of in vitro diagnostic products. Designs and executes strategic Marketing studies. 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). 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 located 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 regualtory 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.
Designs and executes strategic Marketing studies. Leverages/expands clinical study designs to incorporate additional studies that drive innovation, differentiation and competitive advantage. Identifies and facilitates academic collaborations and interactions with opinion leaders that are aligned with company goals. Reviews and tracks approved Investigator Initiated studies (IIS) for study progress, deliverables and payments.
Interprets applicability of current regulations and guidelines pertaining to clinical research and serves as the department expert. Maintains and updates procedures and processes related to IVDR and drives compliance. Represents Clinical Affairs in external initiatives, councils, collaborations and industry organizations involving clinical research to share and leverage clinical expertise and best practices.
Supports company cross-functional strategic business integration and process improvement initiatives and special projects.
Participates in the development and maintenance of SOPs and/or initiatives and departmental coaching/ mentoring for the development of clinical personnel.
Perform other work-related duties as assigned.
The Individual
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. MD/PhD highly desired.
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.
Knowledge of regulations and standards (CFR, GCP, ICH, ISO, QSR, etc.) affecting IVDs and biologics required.
Ability to deal with ambiguous situations, perform work effectively with a high degree of independent judgment without direct oversight with multi-level teams, 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 execution of clinical studies.
Demonstrated track record of leadership of clinical studies. Has directly lead clinical studies used in FDA 510k, PMA and BLA submissions & CE declarations. Experience with clinical studies in China is desirable.
Expertise in clinical data review and statistical analysis.
Demonstrated prior experience with strong client and vendor relationship management skills.
Demonstrated and effective interpersonal, communication and negotiation skills for a wide variety of audiences.
Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates.
Domestic and international travel up to 30% on an annual basis.
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 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.
EOE/AA Disability/Veteran
#LI- Remote
Expected salary: $88000 – 176000 per year
Location: Rochester, NY
Job date: Sat, 31 Jul 2021 07:15:28 GMT
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