- Liaises with the Project Manager to develop centralised monitoring set up and data review timelines and works with the centralised monitoring team to implement these plans.
- Co-ordinates the creation of the Risk Assessment Categorisation Tool (RACT) with all study team members to agreed timelines.
- Proposes potential Key Risk Indicators (KRI) advising on their configuration and use.
- Creates the Centralized Monitoring Plan with the assistance of study team members.
- Oversees the configuration of the analytics tool to agreed timelines.
- Performs complex analyses and root cause analyses to connect related signal to risks, and responsible for ensuring delivery of high-quality, on time results
- Ensures that all relevant documentation is filed in the eTMF.
- Oversees each centralized monitoring cycle to ensure that all findings are correctly documented and actions agreed with the study team.
- Provides training to the study team regarding the study specific centralized monitoring process when required.
- Coaches/mentors CMA team.
- Responsible for timelines, budget and quality of Centralized Monitoring Team deliverables, identification of risks and issues and escalation to Project Manager (PM).
- Provides input into proposals when required.
- Actively participates in preparation, attendance and presentation of bid defence or any other study related meetings as required.
- Where requested line management responsibility for nominated CMAs.
- Typically reports to Director, Centralized Monitoring
- Collaborates with Project Management, Clinical Trial Leaders, Data Management, Medical Monitors, QA and other departments to ensure the safety of subjects and quality of study data
- Liaises with clients as requested by the PM
- Bachelor's degree or equivalent and/or health science background with 5 years of experience in clinical research.
- Previous experience of centralized monitoring is required.
- Ability to manage teams to meet project requirements.
- Understanding of clinical/medical data, including listings and summary metrics.
- Strong customer focus.
- Strong analytical /problem-solving skills / judgment in decision making.
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
- Solid computer skills, including the ability to learn and use interactive computer systems and good knowledge of MS Office (Word, Excel, PowerPoint).
- Results and detail-oriented approach to work delivery and output.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Strong written and verbal communication skills including good command of English language.
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/hybrid* working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
-
Infrastructure Specialist
3 dni temu
Michael Page Warsaw, Polska W pełnym wymiarze godzinTechnologies-expected : SQL responsibilities : Osoba zatrudniona na tym stanowisku będzie odpowiedzialna za poprawne funkcjonowanie, wykrywanie zagrożeń, aktualność, hardening i rozwój infrastruktury IT Organizacji. · Pod opieką osoby zatrudnionej będą: sieć wewnętrzna, zewnętrzn ...
-
Cloud Data Architect
1 dzień temu
hirely Warsaw, PolskaSpółkę HIRELY tworzą profesjonaliści, którzy posiadają wiele lat doświadczenia w takich obszarach jak: IT, BI, zarządzanie projektami i przedsiębiorstwami. Cechuje nas wysoka jakość i efektywność realizowanych projektów poprzez właściwe dopasowanie kandydata do profilu poszukiwan ...
-
AWS Cloud Operations Tech Lead
1 tydzień temu
Oerlikon Business Services Europe Sp. z o.o. Warszawa, PolskaExpected, AWS technologies and toolsYour responsibilities, Professional team lead of AWS support engineers, Responsible for AWS applications assigned to the team, Provides 2nd level proactive support, Actively monitors and maintains internal tickets and alerts, Analyzes and troub ...
-
System Expert Production Platforms
1 tydzień temu
Zf Group Warsaw, Polska W pełnym wymiarze godzinSystem Expert Production Platforms Miejsce pracy: Warszawa Technologies we use Expected AWS Ansible Terraform Grafana Operating system Windows About the project The IT System Expert Production Platforms takes care of application architecture in a professional mode according to IT ...
-
Senior Coordinator
2 dni temu
Colliers Warsaw, Polska Pełny etatOpis stanowiska · Twój zakres obowiązków: · Tworzenie procesów oraz strategii dla marketingu. · Budowanie i wdrażanie lejków marketingowych (generujących SQL). · Planowanie i wdrożenie analityki oraz ustanowienie KPI. · Planowanie treści pod różne Buyer Persony i kanały dotarci ...
-
Product Owner
6 dni temu
BinaryCortex LLC Warszawa, PolskaExpected, ClickUp, JiraAbout the project, A European-based engineering team is seeking a product owner to help build the best platform for discourse and debate on the news of the day. Our small, nimble team is looking for another team player who knows Agile processes, writes exce ...
-
Societe Generale SA Oddzial w Polsce Warszawa, PolskaExpected, Java, Spring framework, Angular, SQLOperating system, WindowsAbout the project, Pilotage 1 (PIL1), Pitotage 2 (PIL2) and Pilotage (PIL3) are client centric and autonomous feature teams working on the same application Financing Business Monitoring and having their own ba ...
-
Enterprise Supply Planning
1 tydzień temu
Blue Yonder Warszawa, PolskaOperating system, WindowsYour responsibilities, Triage & resolve customer/internal raised cases related to Blue Yonder Supply Chain applications (Enterprise Supply Planning, Sequencing), Provide excellent customer experience and solution support to strategic BY customers with own ...
-
Aws Cloud Operations Tech Lead
4 dni temu
Oerlikon Business Services Europe Sp. Z O.o. Warsaw, Polska W pełnym wymiarze godzinTechnologies-expected : AWS technologies and tools responsibilities : Professional team lead of AWS support engineers Responsible for AWS applications assigned to the team Provides 2nd level proactive support Actively monitors and maintains internal tickets and alerts Analyzes an ...
-
Swift Developer with background in Mathematics
1 tydzień temu
EAGER DEVELOPERS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ Warszawa, PolskaExpected, iOS, Swift, Objective-C, C#About the project, Client is a groundbreaking new welltech app transforming the wellness space with a new and electric world of functional breathwork that's immersive, entertaining and scientifically measurable., , Our cutting-edge, scientific ...
-
Payment Risk Identification Manager
5 dni temu
G2A Warsaw, PolskaG2A.COM is the world's largest and most trusted marketplace for digital entertainment, where more than 30 million people from 180 countries have purchased over 100 million items. Users can choose from more than 75,000 digital offerings incl. games, DLCs, in-game items, as well a ...
-
Project Manager With German
4 dni temu
Itds Polska Sp. Z O.o. Warsaw, Polska W pełnym wymiarze godzinTechnologies-expected : Microsoft Excel about-project : As a Project Manager, you will work for our Client – The EU's leading bank and key player on the international banking scene, operating in 72 countries. · You will join a brand new, state-of-the-art, technology and developme ...
-
Head of IT Department
1 tydzień temu
Trinetix Warsaw, Polska W pełnym wymiarze godzinThe Head of IT Department is a pivotal member of the senior management team at Trinetix Inc., responsible for overseeing the IT infrastructure across the organization, including the management of Administrators, HelpDesk, and the forthcoming Cybersecurity team. Reporting directly ...
-
Senior IT Analyst
1 dzień temu
Experis Manpower Group Warszawa, Warszawa, Polska W pełnym wymiarze godzinRequirements: · 10+ years with IT projects · 4+ years as Senior IT Analyst · Responsibilities: · Knowledge in capturing and documenting business requirements and converting these into the foundation for IT design and development · Clarify, document, and communicate functional and ...
-
BI Team Leader
3 dni 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: · Aristocrat Interactive is a leader in the Online Real Money Gaming space offering solutions spanning game co ...
-
It Support Manager @
1 dzień temu
Cpl Poland Warsaw, Polska W pełnym wymiarze godzinFor our client - an Polish consulting company providing complex IT services for business - we are looking for experienced IT Support Manager. · Join the team and... Lead 10-ppl team that provides support for external customers Supervise and coordinate IT tasks, incidents/problems ...
-
Junior Desktop Engineer
1 tydzień temu
Ryanair Sun Warsaw, Polska W pełnym wymiarze godzinAbout-project : The Infrastructure team are currently recruiting for a Junior Desktop Engineer. · Reporting to Labs desktop team Lead/IT Service Manager, this position is permanent and based in our Buzz HQ office in Warsaw. · responsibilities : Responsible for the ongoing mainten ...
-
Project Manager with German
2 dni temu
ITDS Warszawa, Polska W pełnym wymiarze godzinAbout the project · As a Project Manager, you will work for our Client – The EU's leading bank and key player on the international banking scene, operating in 72 countries. You will join a brand new, state-of-the-art, technology and development Hub created to bring together the s ...
-
Johnson Controls International Warsaw, Polska W pełnym wymiarze godzinAre you interested in gaining international work experience? Then Johnson Controls could have the perfect opportunity for you. We are looking for German speakers who can also speak English to join our dynamic team in Bratislava, Slovakia. · If you already have experience with ord ...
-
DevOps Engineer
4 dni temu
Check Point -, Warszawa, Polska W pełnym wymiarze godzinPassionate about shaping the future of cybersecurity? Join Check Point as a Senior DevOps Engineer and contribute directly to safeguarding businesses worldwide. · We offer unmatched opportunities for career advancement, top-tier equipment, and free DevOps certification training. ...
Centralized Monitoring Lead - Warsaw, Polska - Allucent
Opis
At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Centralized Monitoring Lead (CML) to join our A-team (hybrid*/remote). Centralized monitoring is a process used to review key data and metrics generated during clinical trials to assess risk. Using statistical analyses, the team works to identify meaningful signals to characterise issues and offer resolutions and a proactive approach to maintaining data quality. The Centralized Monitoring Lead (CML) coordinates the set-up of study specific processes and the activities of the Centralized Monitoring Analysts (CMAs) during each data review cycle.
In this role your key tasks will include:
Working Relationships:
Requirements
To be successful you will possess:
Benefits
Benefits of working at Allucent include:
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .
"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." #LI-JC1
