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Job Title
Clinical Operations Manager - FSP ( RA Submissions & Budgets)
Company
PAREXEL International Corporation
Job Description
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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it
With Heart
™.
Clinical Operations Manager - FSP ( RA Submissions & Budgets)
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Job ID
83636BR
Stockholm, Stockholm County, Sweden
PAREXEL FSP is currently looking for an experienced Regulator & Submissions Manager to join our expanding team.
Hybrid home/office-based. Stockholm
Two types of roles are available:
The Clinical Operations Manager COM-R is accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
The COM-F, under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD), is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals, and to ensure site ready.
Qualifications
· Bachelor’s Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
· Mandatory – at least 1-year experience in Poland EC and RA submission (must be familiar with XML completion) – including initial submission and protocol amendments submission.
· Experience in Independently preparing submissions (CTC supports with documents collection) to both EC and RA.
· Experience in ICF preparation using templates.
· Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
· Experience in IMP supplies management at the local level (vendors providing background meds, the standard of care, etc.)
· Experience in validation of translated documents.
· Experience with country and site budget including development,
negotiation, and completion of Clinical Trial Research Agreements
and oversight and tracking of clinical research‐related payments and Payment reconciliation at study close‐out.
We offer exceptional financial rewards, training, and development. Expect exciting professional challenges, but with a healthy work/life balance. We value your welfare just as high as that of our patients.
About Parexel FSP:
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
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