Manager/Sr Manager or Assoc Dir, Epidemiology RWE - FSP model - Single-sponsor (remote - Poland[...] in London

Job Responsibilities

• Provides direction from a scientific perspective serving as an expert resource to staff and senior management, within one or more scientific areas.
• Maintains a familiarity with clinical and epidemiological practice guidelines, clinical research models, protocol designs, real world development trends, and regulatory expectations.
• Provides overall scientific oversight of selected projects, responsible for meeting or exceeding customer expectations for timelines, budgets, quality, and overall satisfaction.
• Acts as consultant to or leads the implementation and conduct of the study from a scientific perspective for RWLP projects including protocol writing, statistical analysis, training of RWLP associates, and project related safety monitoring and signal detection, and authorship of publications (interim/final study reports, scientific abstracts and publications).
• Works with RWLP management, business development, and operations personnel to develop and win global business opportunities; provides input into feasibility analysis to determine whether a study of the client’s issue/problem is feasible; proposes the study design; provides input into the proposal and budget; helps to develop and deliver bid defenses and capabilities presentations.
• Responsible for the continued building of organizational capacity, improvement of scientific and operational processes and methodologies for non‑traditional site management tasks (i.e., remote or central monitoring approaches, minimized regulatory document collection, etc.), integrated RWLP technology solutions including secondary database resources, and RWLP Standard Operating Procedures (SOP) development and maintenance.
• Develops and recommends techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state‑of‑the‑art practices.
• Works collaboratively across the organization to help develop business opportunities in the area of post marketing safety commitments and/or risk management.
• Works to develop collegial relationships with sponsors, thought‑leaders and clinical investigators.
• Develops abstracts, provides podium presentations, and leads authorship of articles, manuscripts, etc. in industry and peer‑reviewed journals to promote Company services.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Responsible for providing scientific expertise, organizational infrastructure and business development support for REAL World Late Phase (RWLP), leading study design development and provides scientific and analytic oversight for project deliverables, authoring publications and produces high quality RWE research.