Company: INC Research
Closing Date: 16 Dec 16
Salary (£): Negotiable
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development.
We are currently looking to strengthen our data management team and are seeking CDA III to be based in our UK, Lewes office.
A brief summary of duties you will be involved in as:
Performs advanced Case Report Form /electronic Case Report Form (CRF/eCRF) data review with increased independence and efficiency as compared to data management roles. Performs in compliance with Standard Operating Procedures/Work Instructions (SOPs/WIs), regulatory directives, and study specific plans and guidelines. Performs essential functions which support database testing, as well as additional data management activities such as Serious Adverse Event (SAE) and external data reconciliations.
•Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
•Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
•Enters test data for data entry screens.
•Enters test data for edit checks.
•Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the CRF database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Clinical Data Validation Plan for the assigned projects. Resolves queries correctly answered and re-queries where appropriate. Provides assistance and guidance to other Clinical Data Associates with the above tasks.
•Reviews queries, self evident corrections and the application of global rulings, proposed by less experienced Data Management staff.
•Reviews queries raised by staff responsible for the coding of CRF terms for adverse events, medical history, and medications against medical coding dictionaries.
•Issues queries to sites.
•For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly.
•Ensures that data from external databases/datasets such as laboratory databases, or electronic diary datasets are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.
•For paper studies, performs internal audit and quality control checks on listing output from database against Case Report Forms (CRFs) and Data Clarification Forms (DCFs). For EDC studies, performs DM Review (Rave) and/or other internal audit and quality control checks as required per applicable EDC systems.
•For paper studies, ensures all Case Report Forms (CRFs) and Data Clarification Forms (DCFs) received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
•Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
•Participates in internal meetings.
•Participates in customer and third party meetings, distributing relevant information in advance; ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution.
•Participates in internal/external audits.
•Trains and mentors data management staff providing timely feedback to trainee and management as appropriate.
•May design, or review designs, for CRF pages and e-CRF entry screens and associated CRF/eCRF visit structure, indexing and version control, coordinating with team members responsible for the associated database design.
•Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business.
BA/BS degree in the biological sciences or related disciplines in the natural science/health care field. Nominal Data Management experience, or equivalent combination of education and experience. Experience with Data Management practices and relational database management software systems preferred. Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred. Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills. Effective oral and written communication skills. Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2015 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
European Head Office
River View, The Meadows Business Park,
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