Global Study Manager II - Poland/Spain - 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.

Parexel is actively recruiting for an experienced Global Study Manager to join us in Poland/Spain.

In this role you will provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.

You will be responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis.

Some specifics about this advertised role

• Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).

• Verifies and provides input into the country allocation and oversees trial feasibility.

• Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.

• Prepare and implement amendments of core documents, including training material updates/retraining as needed.

• Support authority/ethics response to requests as applicable

• In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports trial medical writer in providing the CTR.

• Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.

• Support results/documents disclosure of global registries.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience

• Experience with oversight of CROs and vendors

• Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend

• Fluency in written and spoken English required

• Ability to work outside of core business hours, as required, to support global trials or initiatives

• Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings

• Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.

• Knowledge of ICH GCP and relevant regulatory guidelines/directives.

• Demonstrated interpersonal & leadership skills.

• Ability to understand and implement the strategic direction and guidance for respective clinical studies.

• Effective communication skills via verbal, written and presentation abilities.