Medicover Integrated Clinical Services (MICS) is a specialised business unit with the objective to help bring innovative therapies and diagnostics to the market. MICS is focusing on clinical applications and clients from pharmaceuticals, diagnostics biopharma, biotech, contract research organisations (CROs), biobanks, and other players. We have been providing bespoke services to our clients and their patients for over 20 years, making strategic use of Medicover assets, including laboratories with state-of-the-art diagnostic equipment, medical clinics and hospitals, as well as the vast expertise and enthusiasm of a workforce that has grown to more than 28,500 professionals.
MICS’ services include and are organised along discrete lines of activity, including: Central Lab Services, Biospecimen Management, Patient Recruitment, Management and Data, and Precision Medicine. Tightly integrated in all Medicover geographies and beyond, MICS employs a dedicated team of highly specialized experts including clinical and diagnostics experts, contract research professionals, account managers, project managers, logistics, regulatory and commercial experts.
The major markets are Germany, Ukraine, Romania and Poland.
Due to fast growth of Medicover Integrated Clinical Services (MICS) we are looking for new Analytical Project Manager. The opportunity to become a member of a team with many years of experience in managing clinical trials.
We are located in one of the newest offices close to the heart of Gdańsk.
- Responsible for the overall conduct of the analysis being performed by the trial facility and for its report;
- Responsible for ensuring that all tasks reflecting the conduct of analytical project will be achieved;
- Responsible for setting all tasks of the project to the proper members of the team;
- Responsible for ensuring that all Sponsor’s/CRO’s requirements will be achieved;
- Responsible for set-up and maintenance of realization of the active analytical project;
- Responsible for working in accordance to actual regulatory guidelines and internal SOPs;
- Preparation of project plan from operational perspective and Analytical Plan;
- Preparation of project specific documentation;
- Approving the Analytical Plan;
- Communication (trainings) of each new study specifications to all teams involved;
- Management of project-specific queries from clients;
- Ensure the procedures specified in Analytical Plan are followed, and that authorization for any modification is obtained and documented together with the reason for changes;
- Ensure that all results of the analyses are fully documented and recorded;
- Sign and date Final Analytical Report, if issued, to indicate acceptance of responsibility for the validity of the results and to confirm compliance with GCLP;
- Ensure that all project team members will be trained at the project requirements;
- Key contact for Sponsor/CRO;
- Ensure that all documents rising during the conduct of Analytical Plan are signed and dated by designated persons;
- Ensure that all laboratory results will be sent to sites/CRO properly;
- Ensure that after completion of analyses, all documents, i.e. Analytical Plan, Analytical Report, analytical results, raw data and supporting documents are archived and retained;
- Management of accomplishment of the assigned tasks by the study team;
- Ensure that contractual agreed timelines are met;
- Allocation of project-related resources;
- Together with QAU representative, ensuring the compliance of MICS CLS services with protocol and client's requirements within contractual limitations.
- Education:
- Master’s degree (preferable - PhD);
- At least 3 years of relevant experience;
- Laboratory experience is a must;
- Must be experienced in customer service and possess excellent organization and interpersonal skills.
- Language Ability:
- English - fluent, other languages preferable;
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations;
- Ability to write reports, business correspondence, and procedure manuals;
- Ability to effectively present information and respond to question from groups of managers, clients, customers, and general public.
- Math Ability:
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume;
- Ability to apply concepts of basic algebra and geometry.
- Reasoning Ability:
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist;
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or scheduled form.
- Computer Skills:
- To perform this job successfully, an individual should have advanced knowledge of Microsoft Office applications including Word, Excel, PowerPoint.
- Full-time;
- Hybrid-work;
- Contract of employment;
- Work flexible hours;
- Medical Care;
- Multisport Card;
- Private insurance.