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Job Information

J&J Family of Companies TECA Clinical Research Manager in West Chester, Pennsylvania

Clinical Research Manager Responsibilities:

In this role as Clinical Research Manager within the Preclinical, Clinical Medical, this individual has a strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.

Position Duties and Responsibilities

Contribute to the development and delivery of global EGS / EDS to support NPD and LCM within the assigned projects:

  • Ensure input and strong alignment from market leads of strategically important countries/regions in the development of the EGS / EDS;

  • Partner with internal partners to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement

  • Lead interpretation and dissemination of all evidence generated, based on EDS, including reports, abstracts, manuscripts, Clinical Evaluation Reports, etc;

  • Support the collaboration with investigators to deliver and disseminate evidence.

    Write high quality clinical documents to support the development, regulatory approval, and maintenance of our products:

  • Documents include clinical protocols, investigator’s brochures, post-market clinical followup plans and clinical study reports, as well as detailed summaries of efficacy and safety and responses to health authority questions.

  • Interpret and summarize statistical and medical information, and attention to detail to the design of clinical trials and reporting of our data;

  • Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization;

  • Drive team’s collaboration with opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc;

    Cultivate strong relationships with external partners to shape and influence relevant policies.

    Develop a strong understanding of the pipeline, product portfolio and business needs.

    This is not an extensive, comprehensive listing of job functions. May handle other activities as assigned.

Qualifications

Education & experience requirements:

  • A Doctoral Degree or equivalent degree in Biological Science or related field is required.

  • 8 years of relevant clinical / scientific work experience, including leadership functions.

  • A minimum of 1 year project management/leadership experience within clinical research is required.

  • A minimum of 1 year people management experience is required.

  • Broad understanding of product development processes, team dynamics, digital healthcare market environment, and clinical trends

  • Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects;

  • Proven track record in delivering clinical programs within clinical / surgical research setting in compliance to SOPs and regulations;

  • Ability to lead teams to deliver critical milestones;

  • Ability to collaborate across different functional areas within CR&D to ensure alignment with governing processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.). and to meet business objectives;

  • Demonstrated interpersonal skills to build relationships with internal / external business partners

  • Ability to influence decision-makers up and down one or more levels, with and without direct authority, to ensure a fully-aligned evidence strategy.

  • Change agent in team development and progression;

  • Experience in effective management of project budget processes

  • Through transparent leadership, be a key leader in developing a Clinical Research team with a global culture.

    Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Primary Location

United States-Pennsylvania-West Chester-1301 Goshen Parkway

Other Locations

Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil

Organization

Medical Device Business Services, Inc (6029)

Job Function

R&D

Requisition ID

2105973941W

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