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[Full-time] Clinical Data Associate II (CDA II) (Cmed CRS) at CMED

2010-05-02 12:35:32

Location: Anywhere
Description:

Job Description

Job Title: Clinical Data Associate II (CDA II) (Cmed CRS) At Interview Stage

Reports To: Team Manager or Principal Clinical Data Manager

Department: Data Management Operations (DMO)

Core Responsibilities

Provide professional administration and data management of clinical trial data. Identify and request clarification of inconsistent and incomplete data. Ensure resolution to errors in order that databases can be declared clean and locked according to ICH GCP standards.

Principal Accountabilities

Review clinical trial documentation e.g. protocol, validation document and Case Record Forms (CRFs) and provide input as appropriate. Contribute to the design and user acceptance testing (UAT) of new clinical trial databases and validation programming

Maintain accurate documentation and filing systems to ensure safe and secure storage of data

Ensure ongoing data entry from CRFs or other sources into the clinical trial database as documented in the Data Management Plan (DMP), within agreed timeframes and to a high standard of accuracy

Perform relevant Quality Control (QC) checks on the entered data to ensure accuracy. Apply Self Evident Data Corrections (SEDCs) as appropriate, and as documented in the DMP

At the discretion of the Trial Data Manager, perform “first line validation” – generate and send data queries and initiate their resolution via the Sponsors preferred approach. Perform data edits on return of the resolution as appropriate, and perform QC checks of other team members data query resolutions

Identify and resolve errors or inconsistencies raised via manual review and listing review

Maintain an accurate status of data and query processing, e.g. data entered, cleaned and (QC’d). Be able to provide status information on allocated data to the Trial Data Manager

Ensure relevant Sponsor and / or Cmed CRS Working Practices or Standard Operating Procedures are adhered to

Communicate effectively and as appropriate with the Sponsor e.g. via e-mail with Study Monitors in order to manage allocated data

Assist and act as deputy for Clinical Data Manager

Assist in coaching of new or inexperienced Clinical Data Associates I and II (CDAI, CDAII)

Provide input to improving the effectiveness of the organisation such as developing new processes, systems and Customer relations

Ensure timely and accurate entry of relevant study information and time recording occurs in the Management Information System (MIS)

Other tasks as assigned by Team Manager

Essential Work Experience And Qualifications

Preferably degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience

Or 1 years experience in drug development ideally in the discipline of data management

Foreign language skills would be advantageous.

Attributes

Good organisational skills
Good interpersonal and communication skills, and the ability to operate effectively in a team environment
Work calmly under pressure and meet deadlines
Professional, positive, dynamic and driven
A basic understanding of medical terminology, clinical trial methodology and ICH/GCP and the drug development process
An investigative and meticulous approach to all activities and tasks
Transparent approach, clear and precise
Team player
The ability to work effectively and efficiently with internal partners within Cmed
Eagerness to learn and develop new skills

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[Full-time] Head of Clinical Data Management (Romania) (Cmed CRS) at CMED

2010-04-23 08:53:39

Location: Anywhere
Description:

Job Description

Job Title: Head of Clinical Data Management (Cmed CRS)

The purpose of this pivotal role will be to oversee, direct and co-ordinate all activities and resources within clinical Data Management Operations (DMO) in Romania.The successful candidate will ensure that all aspects of DMO projects are managed to the highest level, are on schedule, and within budget. They will work on the development and execution of Cmeds clinical data management operations strategy working with colleagues from Cmed’s UK Head Office. The role will also support and implement initiatives to improve/change the processes for data management operations. In addition, a key part of the job will be to develop positive working relationships with both existing and prospective clients (from both Major Pharma and Biotech) and to work effectively with partners in Cmed.We provide a competitive salary, plus excellent training, personal development and great career prospects. Our Romanian office is based in the friendly city of Timisoara which lies on the Bega River, in Western Romania. Just six miles from the centre is the Traian Vuia International Airport, which connects the city to the UK, France, Germany and many other European destinations. As the area’s largest city, Timisoara offers vibrant culture and cosmopolitan living. In a nutshell, Timisoara offers a varied and exciting way of life, to which you’ll be welcomed with open arms.

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[Full-time] Biostatistician (Cmed CRS) at CMED

2009-10-02 10:06:51

Location: Anywhere
Description:

Job Description

Job Title: Biostatistician (Cmed CRS)

Reports To: Head of Biostatistics & Statistical Programming

Department: Biostatistics

Core Responsibilities

The provision of expert statistical input and consultancy to Phase 1-4 global clinical trials including design of clinical trials and production of analysis and reporting deliverables on behalf of and/or in conjunction with Cmed clients.

Provide input as appropriate into all meetings, discussions and activities covering all statistical aspects for assigned trials
Provide statistical input (as appropriate) into study protocol and CRF to ensure that both documents meet the requirements of the study and of Cmed’s client(s). Ensure adherence to standards (client and/or Cmed), relevant regulatory guidelines and the provision of good statistical practice
Generate and review randomisation lists and code-break envelopes in accordance with Cmed and/or client procedures
Provide statistical input to the Data Management Validation Plan to ensure delivery of appropriate high quality clinical data suitable for statistical analysis and reporting
Author and/or provide input to trial Statistical Analysis Plans. Write detailed statistical methods according to the requirements of the protocol. Prepare table, listing and figure shells in conjunction with the Statistical Programmer(s). Chair analysis planning meetings with internal and external customers (as appropriate)
Perform ongoing review of clinical data from Cmed/client databases to identify potential issues with data impacting the statistical analysis
Program and conduct statistical analyses and provide high-quality statistical output for inclusion in clinical trial reports
Provide expert statistical input to clinical trial reports (as appropriate). Write statistical methods section and review results and conclusions for appropriate statistical interpretation of results.
Responsible for quality control of all statistical analysis deliverables and quality assurance of programming deliverables provided by the Cmed Statistical Programmer(s) for assigned trials
Maintain professional and proactive interactions with internal and external customers
Maintain up-to-date knowledge on statistical techniques and procedures by attendance at professional courses and conferences and by ongoing review of statistical literature
Review the clinical database for acceptance for statistical analysis prior to database lock (as appropriate)
Ensure maintenance and appropriate filing of trial statistical documentation for delivery to Cmed clients
Assist in the development of ‘best-in-class’ analysis and reporting processes to ensure operational efficiency of Cmed Biostatistics’ function
Support Cmed Senior Biostatisticians in the production of expert statistical input to clinical development programs, ISS, ISE and other forms of integrated statistical analyses.

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[Full-time] Senior Statistician (Cmed CRS) at CMED

2009-10-02 10:06:01

Location: Anywhere
Description:

Principal Accountabilities:

Quality assurance of statistical deliverables of other Biostatisticians within the department.
Provide statistical consultancy to clients with regards to design of clinical development programs and/or trials.
Provide statistical input (as appropriate) into study protocol and CRF to ensure that both documents meet the requirements of the study and of Cmed’s client(s). Ensure adherence to standards (client and/or Cmed), relevant regulatory guidelines and the provision of good statistical practice.
Generate and review randomisation lists and code-break envelopes in accordance with Cmed and/or client procedures.
Provide statistical input to the Data Management Validation Plan to ensure delivery of appropriate high quality clinical data suitable for statistical analysis and reporting.
Author and/or provide input to trial Statistical Analysis Plans. Write detailed statistical methods according to the requirements of the protocol. Prepare table, listing and figure shells in conjunction with the Statistical Programmer(s). Chair analysis planning meetings with internal and external customers (as appropriate).
Review the clinical database for acceptance for statistical analysis prior to database lock (as appropriate).
Program and conduct statistical analyses and provide high-quality statistical output for inclusion in clinical trial reports.
Provide expert statistical input to clinical trial reports an/or publications (as appropriate). Write statistical methods section and review results and conclusions for appropriate statistical interpretation of results.
Responsible for quality control of all statistical analysis deliverables and quality assurance of programming deliverables provided by the Cmed Statistical Programmer(s) for assigned trials and/or projects.
Maintain professional and proactive interactions with internal and external customers.
Maintain up-to-date knowledge on statistical techniques and procedures by attendance at professional courses and conferences and by ongoing review of statistical literature
Ensure maintenance and appropriate filing of trial statistical documentation for delivery to Cmed clients.
Assist in the development of ‘best-in-class’ analysis and reporting processes to ensure operational efficiency of Cmed Biostatistics’ function
Responsible for the specification, programming and statistical reporting of integrated summaries, including ISS, ISE, CER and other meta-analytic techniques.
Generate cost estimates for statistical activities in response to client requests
Perform budget tracking for assigned trials and alert Head of B&SP to potential cost overruns/out of scope activities. Ensure project and resource tracking sheets are accurate and updated as required.
Provide input to the appraisal process when required.
Provide input into recruitment process including interviewing.
Ensure timesheets are accurate and updated on a weekly basis.

Essential Work Experience and Qualifications

Minimum of a masters (M.Sc.) or equivalent in Medical Statistics in conjunction with at least four years experience in the application of statistics in clinical trials at a CRO or pharma company.
At least two year’s experience in programming and reporting inferential statistical analyses using SAS.
Expert knowledge of global clinical trial practices, procedures and methodologies (including regulatory guidelines relating to biostatistics).
Experience of project managing (timelines and/or budgets) of statistical activities.
Strong oral and written communication skills (including the ability to communicate statistical concepts and information to non-statisticians)

Attributes Include:

Good organisational skills, plus an understanding of resource & budgeting.
High quality interpersonal and communication skills and the ability to operate effectively in a global working environment.
Work calmly under pressure and meet deadlines.
Professional, positive and enthusiastic attitude.
A thorough understanding of medical terminology, clinical trial methodology, drug development process and ICH/GCP.
A strong investigative and meticulous approach to all activities and tasks.
Transparent approach, clear and precise.
Team player
The ability to delegate tasks.
Assist improving the effectiveness of the organisation such as developing new processes, systems and client relations.
Work effectively and efficiently with internal partners in Cmed.

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