Manager

at PSI CRO AG
🇺🇸 United States - Remote
🏢 Business🟠 Manager

Job description

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together 3,000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

In clinical research, feasibility is often what determines whether a study succeeds or fails. Your insights will directly influence how trials are set up, how quickly they recruit, and how successful they are in meeting their goals. This is a high-impact, strategic role for someone who enjoys writing, deep analysis and cross-functional communications.

  • Analytical Work:

  • Reviews scientific literature, training and potential study materials pertinent to feasibility activities

  • Responsible for final written feasibility and enrollment strategy and risk mitigation plan for assigned projects and presentation thereof to Sponsor

  • Coordinates cross-functional execution of all feasibility services required for assigned projects and standalone feasibility studies

  • Discusses key study elements through questionnaires and Investigator/ KOL interviews

  • Conducts data mining of internal and external databases to recommend operational strategy (optimal site profile, country/ site mix, timelines, and enrollment rates) during proposal through site selection stage

  • Evaluates and recommends sites/ investigators for consideration in future clinical studies based on enrollment capabilities and metrics

  • Participates in scientific conferences, meetings, symposia, etc. to collect information on potential sites/ investigators and obtain in-depth training in the field of the meeting

  • Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies

  • Information and Communication:

  • Liaises with other PSI departments to collate operational feedback and further support feasibility assessments

  • Liaises with Project Management to evaluate the impact of feasibility results on patient enrollment metrics for awarded studies

  • Primary point-of-contact for Business Development and proposal team for assigned feasibility assessments

  • Collaborates with Study Startup to identify and illustrate the value-add of prioritized site relationships and accelerated startup timelines

  • Quality Control & Assurance:

  • Ensures adherence to the PSI/Client’s procedures in all activities pertinent to feasibility research

  • Develops and maintains company Quality System Documents (QSDs) pertinent to Feasibility Department

  • Implements the Quality Control (QC) program aimed at assuring high standards of feasibility research and patient recruitment at PSI

Qualifications

  • Bachelor’s degree required
  • Minimum of 5 years of experience in clinical research
  • At least 2 years of experience in feasibility or patient recruitment
  • Solid understanding of clinical trial protocol design and familiarity with varying enrollment strategies
  • CRO experience strongly preferred
  • Strong critical thinking skills with a proactive, problem-solving mindset; able to work independently and take initiative in areas requiring interpretation and discovery
  • Proven ability to thrive in a highly collaborative, fast-paced team environment; a team-first mindset is essential
  • Excellent written and verbal communication skills, with the ability to clearly articulate scientific and operational concepts across cross-functional teams
  • Advanced proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. You will be part of a collaborative Feasibility team.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

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