- Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
- Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.
- Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
- Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans.
- Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
- Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs.
- Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF
- In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
- Contributing to the nomination and selection of potential investigators and assisting with feasibility activities
- Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed.
- Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO, COML, HCO and/or Quality Group as required.
- Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with PMCO, SML, COLM and Quality Group.
- Minimum of 4 years of CRA monitoring experience
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Excellent knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
- Good understanding of the drug development process.
- Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Excellent attention to details.
- Excellent written and verbal communication skills.
- Excellent collaboration and interpersonal skills.
- Good negotiation skills.
- Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
- Ability to work in an environment of remote collaborators and in a matrix reporting structure
- Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Proactivity and assertivity when communicating with internal stakeholders and sites
- Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
- Experience in all study phases and in rare medical conditions preferred.
-
Clinical Research Associate
1 dzień temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinAlexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland and Barcelona, Spain. We al ...
-
Clinical Research Associate, CDC
1 dzień temu
Novo Nordisk A/S Warsaw, PolskaAre you a dedicated clinical trial professional with solid site management experience? Are you highly motivated by being able to make a difference to improving patients' lives? If yes, keep reading – this role might be just for you · The position · As Clinical Research Associat ...
-
Clinical Research Associate, CDC
6 dni temu
Novo Nordisk Warsaw, PolskaThe position · As Clinical Research Associate your role is to verify the accuracy and completeness of the trial data, that the rights and well-being of human subjects are protected, and the conduct of the trial follows the current approved protocol, GCP and local legislations. A ...
-
Clinical Research Associate, CDC
6 dni temu
Novo Nordisk Warsaw, PolskaAre you a dedicated clinical trial professional with solid site management experience? Are you highly motivated by being able to make a difference to improving patients' lives? If yes, keep reading – this role might be just for you · The position · As Clinical Research Associate ...
-
Research Collaboration Study Sr. Associate
1 tydzień temu
Pfizer Warsaw, Polska W pełnym wymiarze godzinROLE SUMMARY · Research Collaborations (RC) are research studies where Pfizer partners with an external collaborator(s) to develop, conduct and execute research that would be used to support Pfizer business or regulatory goals. The Research Collaboration Study Sr Associate (RCS) ...
-
Experienced Clinical Research Associate SM
4 dni temu
IQVIA Warsaw, Polska W pełnym wymiarze godzinOur team is growing, join us on our mission to drive healthcare forward · What We Offer / USPs · The chance to work on cutting edge medicines at the forefront of new medicines development · IQVIA has access to significant data pools allowing better site selection and recruitment. ...
-
IQVIA Warsaw, Polska W pełnym wymiarze godzinIQVIA is hiring Clinical Research Associates · Join IQVIA today and make an impact on patients' outcome · Job Overview · Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, ap ...
-
Goldman Sachs Warsaw, PolskaA career with Goldman Sachs Asset & Wealth Management (AWM) is an opportunity to help clients across the globe realize their potential, while you discover your own. As part of one of the world's leading asset managers with over $2 trillion in assets under supervision, you can exp ...
-
IQVIA Warsaw, Polska W pełnym wymiarze godzinAre you interested in collaborating with leading pharma companies to help patients all around the world? · When you join IQVIA as a sponsor-dedicated Senior CRA in Poland, you'll enjoy the stability and resources of a leading, global contract research organization while gaining d ...
-
Python Developer
20 godzin temu
Sidnet Solutions Sp. Z O.o. Warsaw, Polska W pełnym wymiarze godzinTechnologies-expected : Python Django Flask SQL Docker about-project : Join our remote team as a Python Developer Join our remote team and get involved in the backend or full-stack development of web applications. · We have a variety of projects, containing elements of computer v ...
-
Redhat System Administrator
2 dni temu
Cyclad Warsaw, Polska W pełnym wymiarze godzinTechnologies-expected : Red Hat about-project : Location: 100% remotely Type of employment: contract of employment or B2 B contract Project language: English Contract length: long-term Start date: depending on candidate"s availability responsibilities : Manage and maintain our Si ...
-
Product Owner
5 minut temu
NeoGames -, Warszawa, Polska W pełnym wymiarze godzin/Only for candidates based in Warsaw or Cracow who are comfortable working on Umowa o Pracę - Employment Contract (no possibility to work on B2B)/ · Project description: · We are NeoGames (Nasdaq: NGMS), a global leader of iLottery solutions and services to national and state-reg ...
-
Senior Clinical Trial Drug Safety Associate
3 dni temu
Everest Clinical Research Services Inc Warsaw, Polska W pełnym wymiarze godzinEverest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies ...
-
Clinical Trial Drug Safety Associate
3 dni temu
Everest Clinical Research Services Inc Warsaw, Polska W pełnym wymiarze godzinEverest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies ...
-
Risk, Credit Risk
7 godzin temu
Goldman Sachs Warsaw, PolskaRISK · The Risk Division is a team of specialists charged with managing the firm's credit, market, liquidity, operational and capital risk. Whether assessing the creditworthiness of the firm's counterparties, monitoring market risks associated with trading activities, or offerin ...
-
Clinical Research Nurse
6 dni temu
Thermo Fisher Scientific Warsaw, Polska W pełnym wymiarze godzinAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources neede ...
-
Risk - Corporate Credit Risk - Analyst/Associate - Warsaw
1 tydzień temu
Goldman Sachs Warsaw, PolskaThe Risk division is responsible for credit, market and operational risk, model risk, independent liquidity risk, and insurance throughout the firm. Risk Division, Corporate Credit Research Group · The Risk division is responsible for credit, market and operational risk, model r ...
-
Senior Associate
2 dni temu
PwC Warszawa, Polska W pełnym wymiarze godzinA career in our Non Financial Services Audit practice, within External Audit services, will give you an opportunity to provide a range of Assurance services and business advice to a variety of clients from small, fast growing clients to large entities. Our clients are often well ...
-
Junior UX Designer
1 dzień temu
Allegro sp. z o.o. Warsaw, Polska W pełnym wymiarze godzinJob Description · A hybrid work model that incorporates solutions developed by the leader and the team · Details regarding our recruitment process and timeline you can find here · What does this role involve · You will learn the entire research and design process in detail and se ...
-
Associate Project Manager
3 dni temu
Innovaderm Research Warsaw, Polska PermanentThe Associate Project Manager ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The Associate Project Manager must ensure compliance with the study budget, project scope and timelines and in accorda ...
Senior Clinical Research Associate - Warsaw, Polska - AstraZeneca
Opis
Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland and Barcelona, Spain. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world, including Poland.
Alexion, AstraZeneca Rare Disease , is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc
Alexion is implementing the R&D team in Poland to support expansion of the footprint and enhance Poland presence in our development plans. In this context, we are looking the the Senior Clinical Research Associate (Sr. CRA), who has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The Sr.CRA works in close collaboration with (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Clinical Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level.
The Sr.CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study.
The Sr.CRA is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
A Sr. CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg. Lead CRA, etc).
You will be responsible for:
You will need to have:
We would prefer for you to have:
Date Posted
21-mar-2024Closing Date
30-kwi-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
Użytkownicy zawodu Senior Clinical Research Associate w Warsaw
-
Kuldeep Singh
Aspiring to handle managerial position in accounts with an organisation of repute, where I can share ...