Feasibility Senior Manager - Poland - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Feasibility Senior Manager, home-based and sponsor dedicated, in Poland.

In this role you will support early evaluations for proposed new studies and undertake evaluations to determine whether a study proposal is viable utilizing in house knowledge, technology capability and other resources as able to provide a scientific based rational for inclusion of countries, sites and potential investigators in new study development.

We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.

As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.

You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

The most significant aspect of this position is

• Ability to evaluate the intent of the study concept and make informed recommendations based on scientific review and information available at the time of the request
• Ability to effectively communicate with key stakeholders through this initial viability/ feasibility concept phase seeking additional information as required to ensure viability output fulfills the team’s requirements.
• Utilization of tools (e.g. Medidata, Symphony (Real World Evidence)) to generate data specific to satisfy feasibility/viability requests
• Authoring of reports to inform project teams of assessment, to include such data as enrolment rates, location of patient populations, local practices, considerations of protocol designs, Site ID and risks.
• Cross functional working (e.g with real world evidence team, GPSS, Clinical Monitoring team) to facilitate processes to support therapeutic landscape evaluations to assist in selection of best countries/ sites to ensure the necessary patient populations are available to aid recruitment for the study
• Author review/verification to support the feasibility/viability team to meet timeline delivery for requests.
   

From you we expect

• Bachelor's degree (or equivalent), Master's degree or health data sciences degree preferred.
• Minimum 5 years of relevant experience in feasibility.
• Scientific understanding for the areas to help support effective viability considerations.
• Excellent knowledge of GCP and regulations.
• Experience of team management.
• Extensive pharmaceutical or related industry experience.
• Ability to author scientific documentation to support viability consideration.
• Utilization of software applications to support data collection and clear interpretation of this data to assist in the evaluation of the study viability.

For an immediate interview, please contact marta.kuniewicz@parexel.com