Associate Director, Clinical Document Anonymization Technology, Clinical Trial Transparency

7 miesięcy temu


Warsaw, Polska AstraZeneca Pełny etat

Location : Warsaw (PL)

Salary: Competitive, with excellent benefits.

Hybrid model of work : 3 days in office, 2 days remote per week

This role sits within the Clinical Document Anonymisation and Data Sharing function in Clinical Trial Transparency, Chief Medical Office. The Clinical Trial Transparency leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally.

The Associate Director Technology is responsible for working autonomously with Systems & Process Owners, business areas IT and vendors to design, implement and refine industry-leading tools that support automated clinical data and documents anonymization. In collaboration with Process Owners and business areas, establishes expectations on systems Quality, Performance and Validation. The candidate is an expert in clinical documents and datasets anonymization demonstrating thorough understanding of clinical study data lifecycle.

This role requiring global cross functional collaboration to ensure best in class Anonymized outputs. The job holder applies appropriate analysis tools to interpret data signals and trends and report bugs, fixes requirements, system upgrades and drives system related improvements. The job holder also delivers anonymized documents for public disclosure and external data sharing.

Typical Accountabilities and required competencies

Manages and refines data and documents anonymization tools, analysis methods and manage system related continuous improvements Establishes, monitors anonymization tools Quality, Performance and Validation to meet business needs and regulatory requirements, in collaboration with end users and customers. Reports bugs, manages fixes and drives communication with vendors to track system upgrades needs. Provides data for periodic and ad hoc quality and compliance reports, presentations and dashboards for AstraZeneca R&D and CTT CDA leadership. Drives the delivery of the anonymized clinical documents Drives real time decisions that balance multiple priorities and stakeholders simultaneously to meet global priorities. Is an expert on the tools, process and policies supporting Clinical Document anonymization Manages key stakeholders in AZ to ensure a cross-functional anonymization approach and ensure that processes, procedures and systems are aligned. Is the key promotor and communicator of “transparency mindset”. Participates and co-ordinates activities in required system testing and validation activities. Provides expert input to global data initiatives and networks. Monitors the anonymization tools landscape and regulatory requirements.

General Accountabilities

Understands the data collected and used in the Clinical Study lifecycle from site through to Clinical document authoring (Understanding of Data Management within Clinical Development) Is an expert on Risk Measurement and quantification of data sets, particularly focused on those used for delivery of EMA policy 0070 Redacted Document Packages and other Regulatory policies globally. Coaches and mentors CT CDA colleagues Provides general support related to systems validation, performance and maintenance Performs the CTT Lead role for assigned Clinical Document Anonymization packages, ensuring full work delivery. Authors Anonymization Reports for assigned packages. Contributes to ensuring all team documentation is kept up to date and relevant, including but not limited to Guidelines, training and other tools.  Participate in forward thinking efforts around proactive writing of CSRs to support automated anonymization (in the world of disclosure) Ensures adherence to all applicable AstraZeneca and external requirements. Establishes best practice to improve quality, productivity, and effectiveness of AZ processes. Contributes to Clinical Trial Transparency leadership and delivery. Manages multiple, parallel projects end-to-end to the satisfaction of customers, to get clinical documents into the publishing stage Proactively learns of new policies, legislation and business processes that arise due to the dynamic and evolving nature of the data and documents-sharing landscape Excellent communication skills and ability to build positive relationships Change Management track record Excellent organisational skills, and ability to balance different projects/priorities and deliver high quality outcomes under pressure

Essential

Experienced project manager with well-developed interpersonal, coaching, influencing and managing skills Knowledge of Best practices in Validated systems delivery and User Acceptance Tests Expert in technology and tools supporting anonymized datasets and documents delivery. Manages technical and logistical services in collaboration with Systems Owners and vendors. Advanced verbal and written communication skills with ability to maintain and create professional networks with stakeholders Advanced and proven problem solving and conflict resolution. Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information Understands how programming is used to deliver technical programming and information components of a study, including but not limited to the following:Study Data Tabulation Model (SDTM) and Analysis Data Model (Adam) data setsTables Figures and Listings (TFLs)Clinical Trial Transparency deliverables (data de-identification, results posting files) Demonstrated knowledge of Clinical Study Reports and other Clinical Documents BSc in mathematics, statistics, engineering, computer science, or life or social sciences.

Desirable

Experience of Operational Excellence, lean principles, processes, tools, behaviours & leadership Demonstrated experience designing and implementing technology solutions and tools. Prior relevant knowledge of a statistical or database programming language (preferably SAS). Medical writing experience, turning Tables Figures and Listings Clinical Study Reports Previous experience as System Owner

Date Posted

05-cze-2024

Closing Date

28-cze-2024

  • Warsaw, Polska Randstad Polska Pełny etat

    We are currently recruiting for the position of Associate Clinical Trial Manager in Poland for a global leader in the diagnostic and medical industry. The person in this role will be part of the Clinical Trials Team, responsible for the planning, execution, management, and closure of projects related to the company's clinical trial plans. A key part of the...

  • Clinical Trial Associate

    1 miesiąc temu


    Warsaw, Polska TFS HealthScience Pełny etat

    The Clinical Trial Associate (CTA) plays a critical role in supporting clinical research projects, ensuring smooth coordination, administration, and documentation of clinical trials. This role ensures compliance with all regulatory and company guidelines.Team: SRSSponsor: You will be dedicated to a global pharmaceutical/biotech leader in innovative drug...

  • Clinical Trial Associate

    1 miesiąc temu


    Warsaw, Polska Randstad Polska Pełny etat

    We are currently recruiting for a Clinical Trial Associate for a global leader in diagnostics/medical industry. This position is responsible for assisting in the execution of clinical trials by providing quality administrative and project management support. If you already have at least one year of experience in clinical trials and have advanced English...

  • Clinical Trial Coordinator

    6 miesięcy temu


    Warsaw, Polska Thermo Fisher Scientific Pełny etat

    At 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 - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...

  • Clinical Trials Associate

    6 miesięcy temu


    Warsaw, Polska Worldwide Clinical Trials Pełny etat

    Requisition Number8201Employment Type:Regular Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. ...

  • Clinical Trial Manager

    7 miesięcy temu


    Warsaw, Polska IQVIA Pełny etat

    Clinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and...


  • Warsaw, Polska Worldwide Clinical Trials Pełny etat

    Requisition Number7944Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...


  • Warsaw, Polska Novo Nordisk Pełny etat

    The 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. As a CRA, you will be representing Novo Nordisk and being the main point of...


  • Warsaw, Polska Thermo Fisher Scientific Pełny etat

    At 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 - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...


  • Warsaw, Polska IQVIA Pełny etat

    Job Overview The Clinical Supply Chain Manager is responsible for managing the strategic planning and execution of a program of assigned clinical supply chain projects. The Clinical Supply Chain Manager will support the ongoing development and optimization of the Clinical Trial Supplies department and processes. Essential Functions Interpret clinical...

  • Clinical Medical Manager

    2 miesięcy temu


    Warsaw, Polska Novo Nordisk AS Pełny etat

    Are you looking for an opportunity where you can utilize your medical knowledge to communicate scientific data and to interact with medical thought leaders? Are you passionate about the world of clinical trials? Are you highly motivated by being able to make a difference to improving patients’ lives? If so, you should continue reading and apply today! ...

  • Clinical SAS intern

    2 miesięcy temu


    Warsaw, Polska Grupa Absolvent Pełny etat

    Informacje o ofercie pracyIntego Group’s office in Warsaw, Poland, is currently seeking students and graduates from local universities to join our internship program.The clinical research industry is a rapidly growing field that leverages cutting-edge data science and biostatistics to improve healthcare outcomes. In our Clinical SAS® Internship Program,...

  • Clinical Project Manager.

    7 miesięcy temu


    Warsaw, Polska PSI Pełny etat

    Job Description Take your career to the next level and lead challenging full-service global clinical research projects, managing the full scope of responsibilities and getting hands-on involvement in every aspect of the study. Your responsibilities will include: Management of global, multi-center clinical research projects in a variety of...


  • Warsaw, Polska IQVIA Pełny etat

    Our 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. This helps drive performance of sites making the CRA role more efficient and...


  • Warsaw, Polska Innovaderm Research Pełny etat

    Clinical Research Associate II, Poland (dermatology and rheumatology CRO)The Clinical Research Associate II (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all...

  • Clinical Trial Coord

    7 miesięcy temu


    Warsaw, Polska Thermo Fisher Scientific Pełny etat

    At 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 - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...


  • Warsaw, Polska Biogen Pełny etat

    Job Description This is a field-based country aligned role, strategically focused on providing key local operational and scientific expertise to drive global clinical development strategy, enable local partnerships that enhance global customer satisfaction (Internal and external), and support the country focused delivery and execution of the R&D...


  • Warsaw, Polska AstraZeneca Pełny etat

    The Associate Director Standards Developer is primarily responsible for leading the technical development, management and maintenance of AZ end-to-end Clinical Analysis & Reporting Standards activities in their area of expertise ( clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness,...


  • Warsaw, Polska AstraZeneca Pełny etat

    Locations: Barcelona, Spain (on-site) Warsaw, Poland (on-site) Mississauga, Canada (on-site) The Global Study Director (GSD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the operational planning and delivery of high priority and complex clinical studies or multiple...


  • Warsaw, Polska AstraZeneca Pełny etat

    The Associate Director, Open-Source Developer, is responsible for ensuring the high-quality, timely, and efficient development of open-source infrastructure for clinical programming and effective information management. This pivotal role demands profound experience in Python, R, and SAS programming, coupled with excellent industry knowledge of creating...