Are you a Senior CRA who is tired of travelling and looking to make their first step in to Project Management?
Do you want to be part of an award-winning clinical research organisation who is positively working towards improving the health and lives of millions?
Clintec have an excellent career opportunity for a determined and motivated Warsaw based Senior Project Specialist who strives for excellence to join our team on a full time and permanent basis, working from our sponsor’s impressive and modern office in Warsaw. This role would suit an experienced CRA who is looking to gain experience that will allow them to move in a Project Management direction, or an experienced Global CTA looking for the next step in their career.
As a Clinical Project Specialist, you will support the delivery of clinical studies within agreed timelines, costs and quality standards. You will be involved in the study from protocol development through study set-up, maintenance, close-out, development of the study report and study archiving. You will work with internal and external partners to deliver aspects of the clinical study alongside the Project Management team.
AS A CLINICAL PROJECT SPECIALIST YOU WILL:
Prepare study documents such as ICF and Clinical Study Agreement, as well as documents related to external service providers
Ensure efficient study delivery by working with other departments such Regulatory, Data Management, QA and Patient Safety, as well external functions like CROs and external service providers
Support meeting planning (including Investigator and Monitor meetings)
Ensure supply of the IP and study materials
Contribute to risk and issue identification and development of mitigation/action plans
Support Project Managers with budget management, such as invoice reconciliation
Supports Project Managers in project management activities and management of CROs
University degree (ideally Advanced level) within Medicine or Biological Science
Significant experience within a related role in the pharmaceutical industry
Knowledge of clinical development / drug development process in various phases of development and therapy areas
Experienced in supportive project management with demonstrated leadership skills
Fluency in English
Good working knowledge of ICH GCP and local regulatory requirements
Excellent communication and relationship building skills
Please note that this is not an entry level role and that significant experience within clinical research is absolutely essential.
WHAT CAN WE OFFER YOU?
At Clintec, we believe our people are our greatest asset and understand that the best performance comes from individuals who know they are part of a valued team. You can expect to receive expert training and guidance throughout your career with us, with the opportunity to develop, progress and travel globally.
We can offer you:
A competitive salary and benefits package including private health care, holiday allowance, sports programme and Christmas vouchers
Opportunity to work with a global pharmaceutical leader in a role fully dedicated to a single sponsor
Opportunity to work on ground-breaking, challenging studies in various therapeutic areas within a stunning, state of the art office environment in Warsaw
Real career development opportunities within a friendly and social team where you can truly shine and make an impact
Clintec (an IQVIA company), established for 22 years, is an award-winning, full-service global clinical research organisation. Our head quarter office is based in Scotland, UK and we have operations across 50+ countries worldwide.
We differ from other players in the clinical research industry as we combine the agility and flexibility typical of smaller CROs with the global coverage and management associated with large CROs.
We provide clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries, assisting with key product development and managing clinical trials across all major therapeutic areas, with expertise in Oncology and Rare Disease studies.
To be considered for this role, please click the APPLY NOW button. Alternatively if you want to know more about job opportunities at Clintec or our company, please visit our website www.clintec.com or contact our internal recruitment team directly at firstname.lastname@example.org.
Clinical Research / Clinical Trials / Clinical Research Professionals / Clinical Research Career / SCRA / Project Specialist / Oncology / Cardiology / Pharmaceutical / Project Manager / Associate Project Manager / Project Support / Project Management