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Clinical Study Manager

Mountain Lakes, New Jersey

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Responsibilities

Location Mountain Lakes, New JerseyUS Job ID JR-020803

Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.

Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.

If you are seeking a meaningful, impactful, and stimulating career, look no further.

PerkinElmer is seeking a Clinical Study Manager, under the supervision of the Associate Director of Regulatory Affairs and Quality Management, who will lead the planning and oversight of clinical development activities to support the validation of assigned assays.

Responsibilities:

Essential responsibilities include but are not limited to:

  • Independently plans and executes clinical studies/validations 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. Initiates clinical designs, protocols and summary reports. Ensures that assigned Regulatory Affairs staff and contractors have appropriate knowledge of relevant analyzer and assay technologies.
  • 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. 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, as needed.
  • Identifies, qualifies, selects, and manages external service providers. 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.
  • Supports company cross-functional strategic business integration and process improvement initiatives and special projects.
  • Perform other work-related duties such as sample procurement/management/inventory and as assigned.


Basic Qualifications:

Education: 

  • Bachelor of Science required in medical, biological or medical specialty.

Experience:

  • Minimum 4 years of clinical study experience, (e.g., IVD, pharmaceutical, medical device, CRO) required.
  • Minimum of 2 years of IVD clinical study/validation experience including the proven ability to oversee clinical teams in the conduct and report of multicenter, complex studies is required.
  • 2+ years of demonstrated individual/team supervisory and management experience.

Preferred Qualifications: 

  • Master's degree in medical, biological or closely related science.
  • Clinical Laboratory Scientist certification [MT/MLS (ASCP) or equivalent]
  • Certification as a Clinical Research Professional (CCRP)
  • Budgetary experience is preferred.
  • Demonstrated track record of leadership of clinical studies. Has directly led clinical studies used in FDA 510k, PMA and BLA submissions & CE declarations.
  • Knowledge of regulations and standards (CFR, GCP, ICH, ISO, QSR, etc.) affecting IVDs and biologics required.
  • Expertise in clinical data review and statistical analysis.
  • 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.
  • 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/validations.
  • 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 travel up to 10% on an annual basis.

Benefits:

Paid Vacation, holiday and sick time

Medical, Dental, Vision Coverage

401k

Tuition Reimbursement

Parental Leave

Adoption Assistance

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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