Senior Initiation Clinical Research Associate - SSU Manager - Serbia - FSP
Belgrade, Serbia Additional Locations Bucharest,Bucureşti,Romania;Budapest,Budapest,Hungary;Kyiv,Kyiv,Ukraine;Prague,,Czechia Job ID R0000030252 Category Clinical Trials Date Posted 01/07/2025Overview
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Flexible
- Organized
- Problem-solver
- Self-starter
About This Role
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 Senior Initiation CRA (SSU Manager), home-based and sponsor dedicated, in Serbia.
In this role you will have responsibility for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS).
The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues.
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
- Support and oversee the study start up activities specific to the region of Europe.
- Provide country and site-specific insight to inform the overall study timeline and milestone projections, as needed.
- Management of PI/site creation, site number assignment, and site statuses in CTMS (candidate, proposed, initiating, active).
- Monitor distribution and collection of site essential documents.
- Monitor relevant member state activities associated with EUCTR (if applicable).
- Review of the first 2 Site Regulatory Packages (SRPs) per country at minimum, including TMF management.
- Management of 1572 reporting notification (if applicable).
- Monitor preparation and distribution of documents supporting the SIV as part of the Investigator Site Files.
- Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include
• Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
• Conduct remote Qualification Visits (QVs). - Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
- Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions, and concerns.
- Conduct remote visits/contacts as requested/needed.
- Generate visit/contact report.
- Review & follow-up site payment status.
- Follow-up on CRF data entry, query status, and SAEs.
- Lead and direct the CRO leadership by answering questions and advising them on IRB submissions and gives final approval for FPFV.
From you we expect
- A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology.
- BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience.
- Minimum 2 years’ experience in startup, site activation and onsite monitoring.
- Skills in more than one language are an advantage in this role; English is required.
- Strong problem-solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Excellent presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks to achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Strong ability to make appropriate decisions in ambiguous situations.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables.
- Excellent time management in order to meet study needs, team objectives, and department goals.
- Proven ability to work across cultures.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a (‘virtual’) team environment.
- Consulting Skills.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Act as a mentor and role model for other team members.
- Effectively enlist the support of team members in meeting goals.
- Attention to detail.
- Holds a driver’s license where required.
For an immediate interview, please contact marta.kuniewicz@parexel.com
Potential Career Path
Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
