Senior Clinical Data Manager

2 tygodni temu

Warszawa, Mazovia, Polska Precision for Medicine Pełny etat

Position Summary:
The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

  • Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
  • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
  • May perform quality control of data entry
  • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
  • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
  • May assist in building clinical databases
  • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
  • May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
  • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
  • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
  • Review and query clinical trial data according to the Data Management Plan
  • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
  • Run patient and study level status and metric reporting
  • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
  • Coordinate SAE/AE reconciliation
  • Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
  • May assist with SAS programming and quality control of SAS programs used in the Data Management department
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
  • May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
  • May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
  • May review Request for Proposals (RFP), proposals, provide project estimates
  • Provide leadership for cross-functional and organization-wide initiatives, where applicable
  • Trains and ensures that all data management project team members have been sufficiently trained
  • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
  • May present software demonstrations/trainings, department/company training sessions, present at project meetings
  • May require some travel
  • Perform other duties as assigned

Qualifications:
Minimum Required:

  • Bachelors and/or a combination of related experience

Other Required:

  • 8+ years' experience
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
  • Able to handle a variety of clinical research tasks
  • Excellent organizational and communication skills
  • Professional use of the English language; both written and oral
  • Experience in utilizing various clinical database management systems
  • Broad knowledge of drug, device and/or biologic development and effective data management practices
  • Strong representational skills, ability to communicate effectively orally and in writing
  • Strong leadership and interpersonal skills
  • Ability to undertake occasional travel

Preferred:

  • Experience in a clinical, scientific or healthcare discipline
  • Dictionary medical coding (MedDRA and WHODrug)
  • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc....)
  • Oncology and/or Orphan Drug therapeutic experience

#J-18808-Ljbffr

  • Clinical Data Associate/Senior Clinical Data Associate

    2 tygodni temu

    Warszawa, Mazovia, Polska Precision Medicine Group Pełny etat

    Precision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific...

  • Clinical Data Associate/Senior Clinical Data Associate

    2 tygodni temu

    Warszawa, Mazovia, Polska Precision for Medicine Pełny etat

    Precision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific...

  • Senior Clinical Data Science Lead

    2 tygodni temu

    Warszawa, Mazovia, Polska 110 ICR Ireland - IRE Pełny etat

    Senior Clinical Data Science Lead page is loaded Senior Clinical Data Science Lead Apply locations Poland, Warsaw Spain, Madrid Spain, Barcelona South Africa, Johannesburg time type Full time posted on Posted 9 Days Ago job requisition id JR119726 ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to...

  • Senior Clinical Data Science Lead

    2 tygodni temu

    Warszawa, Mazovia, Polska ICON Pełny etat

    ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center of all that we do, we help to accelerate the development...

  • Senior Clinical Research Associate- Rheumatoid Arthritis- Poland

    2 tygodni temu

    Warszawa, Mazovia, Polska Worldwide Clinical Trials, LLC Pełny etat

    Who we areWorldwide 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 heritage, our dedicated therapeutic focus on...

  • Clinical Training Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Novo Nordisk AS Pełny etat

    Are you a clinical training professional who enjoys working in a dynamic and multicultural work environment? Do you have experience in designing, implementing, and conducting training programs. Then we might just have the perfect role for you Apply now and become our new Clinical Training Manager. The position The Clinical Training Manager will be...

  • Clinical Training Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

    The Clinical Training ManagerThe Clinical Training Manager will be in charge of creating, implementing, and supervising skill verification training programs for our clinical team.The perfect candidate will possess a solid clinical background, exceptional communication abilities, and the capacity to excel in a dynamic environment.Your primary job...

  • Clinical Trial Oversight Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Amgen SA Pełny etat

    Clinical Trial Oversight Manager in AmgenThe Clinical Trial Oversight Manager at Amgen oversees the conduct of clinical trials, ensuring they are carried out according to protocol, on time, and within budget. They liaise with various teams and external partners to ensure the quality of clinical trial data.Responsibilities:Primary point of contact for FSP...

  • In-house Clinical Research Associate II – EMEA – Home based

    2 tygodni temu

    Warszawa, Mazovia, Polska Worldwide Clinical Trials, LLC Pełny etat

    Who we areWorldwide 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 heritage, our dedicated therapeutic focus on cardiovascular,...

  • Clinical Training Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

    The PositionThe Clinical Training Manager will be responsible for developing, implementing, and overseeing skill verification training programs for clinical staff. The ideal candidate will have a strong clinical background, excellent communication skills, and the ability to thrive in a changing environment.Your key job tasks include but are not limited...

  • Senior Scientist, Clinical Informatics

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca GmbH Pełny etat

    Senior Scientist, Clinical InformaticsLocation: Barcelona, Spain; Warsaw, PolandCompetitive Salary & BenefitsMake a more meaningful impact to patients' lives around the globeHere you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become...

  • Senior Analyst I, Clinical Trial Safety

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    JOB ROLE Join our passionate Research & Development team at AstraZeneca. As a Senior Analyst I, Clinical Trial Safety, you will have a crucial role in reviewing significant amounts of medical data in the clinical trial landscape. Your efforts will guarantee that patient data is accurate, enabling study physicians and clinical/project scientists to...

  • Scientist, Clinical Trial Safety

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    ABOUT DEPARTMENT The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. The primary remit of the TRISARC is to review large amounts of clinical (mainly safety) data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing...

  • Senior Scientist, Clinical Informatics

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    Senior Scientist , Clinical Informatics Location: Barcelona, Spain; Warsaw, Poland Competitive Salary & Benefits Make a more meaningful impact to patients' lives around the globe Here you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab...

  • Senior Analyst, Clinical Trial Transparency Anonymization

    2 tygodni temu

    Warszawa, Mazovia, Polska AstraZeneca Pełny etat

    equire anassociated Typical Accountabilities and required competencies Create Anonymized Clinical Documents following best practices and established SOPs. Contribute to the Anonymization Report for the reports created. Be a system expert in the use of Technology Tool for delivery of Anonymized Clinical Documents. Perform System User Acceptance...

  • Global Clinical Project Manager Warsaw

    2 tygodni temu

    Warszawa, Mazovia, Polska Resourcing Life Science Pełny etat

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Global Clinical Project Manager in Warsaw.Job OverviewLeading cross-functional project teams...

  • Senior IT Project Manager(Big Data, Data Platforms)

    2 tygodni temu

    Warszawa, Mazovia, Polska MUM Fortrea Development India Pvt Ltd Pełny etat

    Senior IT Project Manager(Big Data, Data Platforms) page is loaded Senior IT Project Manager(Big Data, Data Platforms) Apply locations Warsaw, Poland Bangalore India time type Full time posted on Posted 18 Days Ago job requisition id As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical...

  • Clinical Operations Manager, Trial Management

    2 tygodni temu

    Warszawa, Mazovia, Polska Novo Nordisk AS Pełny etat

    Do you want to be part of a dynamic team, working in an international environment that drives clinical trial activities? Do you want to develop further as a people manager within the clinical trials field? Then keep reading - we may have just the right job for you Clinical Development Centre (CDC) Poland is expanding and is looking for a new Clinical...

  • Clinical Project Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska Alimentiv Inc. Pełny etat

    As the primary sponsor liaison and advocate, the Clinical Project Manager will plan, execute, manage and monitor regional, single modality or therapeutic area clinical research projects. Utilizing existing templates, processes and programs as a guide, he or she will adapt/develop, implement, monitor and be accountable for project protocols, operational...

  • Clinical Data Manager

    1 miesiąc temu

    Warszawa, Mazovia, Polska MSD Pełny etat

    Job DescriptionAre you a creative, analytically thinking, and Big Data-oriented last year student? Do you want to gain hands-on experience in data management within an innovative pharmaceutical company and contribute your knowledge and ideas to our team? We are looking for graduating student or Master student, you must be searching for a challenging but...