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Manager, Clinical Trials

New Jersey All, NJ

Post Date: 06/11/2018 Job ID: JN -062018-21803 Job Type: Clinical
  • Lead the planning and oversight of clinical development activities to support the validation of assigned assays
  • Responsible for interpreting medical, scientific and clinical strategy and driving clinical development and trial management of multiple moderate to highly complex clinical programs including, but not limited to, the planning, implementation, oversight, project management and completion of clinical trials conducted by Clinical Affairs or Contract Research Organizations (CRO)
  • Serves as a subject matter expert for clinical studies and serves as a mentor for Clinical Affairs Scientists
  • Drive results through inspired leadership with a focused and disciplined approach to clinical development that is consistent with best practices in the industry
  • He/she will work collaboratively with product management, regulatory, and R&D teams to design, execute and deliver clinical programs
  • Oversee the design and execution of large development programs to support the validation of biomarkers for in vitro diagnostic assays and to support assay product development, regulatory market application submissions of new or reformulated IVD products or additional indications
  • Independently plans and executes clinical studies and applies expertise in clinical data review and statistical analysis
  • Independently develop and present program strategies to ensure that the clinical programs effectively achieve the overall assay product development program objectives within approved budgets and committed timelines
  • Define, track and report schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff
  • Provide thought leadership on cross functional teams for evaluation of new product ideas and implementation of business strategies
  • Identify, qualify, select and manage 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 assess potential risks to the study and propose mitigation plans
  • Prepare and present clinical design proposals and submission review responses to regulatory authorities to ensure adequacy of support for all claims pertaining to safety, efficacy, and clinical performance
  • Identify and facilitate academic collaborations and interactions with opinion leaders that are aligned with company goals
  • Actively participate in external communication and collaborations with thought leaders in clinical development ensuring the highest level of competency and professionalism in all activities and that all projects are aligned to the needs of the customers and business, and that timelines are met
  • Evaluate 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; contribute to the authoring of presentations and publications of clinical study data
  • Develop and advance the organization's policy and procedures for Clinical Affairs and compliance to establish a compliant culture
  • Ensure compliance of program conduct and study documentation practices with company policies and procedures
  • Actively participate in establishing best practices through strategic planning; training and writing/editing appropriate documentation
  • Hire, train and evaluate staff
  • B.S. in Biological Science or Advanced Degree
  • Minimum 10 years of clinical study experience, (e.g., IVD, pharmaceutical, medical device, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies; IVD clinical study experience 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
  • At least 2 years of demonstrated individual/team supervisory and management experience with budgetary responsibility is preferred
  • Demonstrated track record of leadership of clinical studies; has directly lead global clinical studies used in FDA 510k, PMA and BLA submissions & CE declarations
  • Experience with clinical trials 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

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