Clintec is actively recruiting a Project Specialist (PS) to join our expanding global company in Poland. This role is office based in Warsaw. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The PS is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.
The PS works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Project Manager/ Project Leader in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), Project Management Framework, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices (e.g. guidelines) and in line with values and behaviours.
Responsibilities of the Project Specialist:
In partnership with enablement team, other clinical experts and external service providers, the PS provides oversight to ensure study delivery.
Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.)
Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives
Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting)
Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate
Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues
Ensures that all study documents in scope of Project Specialist responsibilities are complete and verified for quality in Trial Master File
Supports Project Manager / Project Leader with budget management, such as external service provider invoice reconciliation
Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times
Supports Project Manager / Project Leader in project management as per agreed delegation
For outsourced studies, supports Project Manager / Project Leader in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
Knowledge of clinical development / drug development process in various phases of development and therapy areas
Excellent knowledge of international guidelines ICH/GCP
Excellent communication and relationship building skills, including external service provider management skills
Experienced in supportive project management
Demonstrated ability to collaborate as well as work independently
Demonstrated leadership skills
Computer proficiency , advanced computer skills in day-to-day tasks
Excellent verbal and written communication in English
Experience in all phases of a clinical study lifecycle
Basic knowledge of GXP outside of GCP (i.e GMP/GLP)
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.