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[Full-time] Team Manager – Data Management Operations (NJ and NC) (Cmed CRS) at CMED

2010-08-19 09:23:31

Location: Anywhere
Description:

Job Description

Job Title: Team Manager – Data Management Operations (NJ and NC) (Cmed CRS)

Reports To: Local Head of Data Management Operations

Department:

Core Responsibilities

Manage, direct and co-ordinate all activities and resources of an allocated team within Data Management Operations. Act as a consultant on the requirements for specific Sponsors and work effectively with Cmed partners globally to ensure high quality, timely and within budget management of clinical trial data.Principal Accountabilities:

Principal Accountabilities

Manage, co-ordinate, oversee and deliver all data management related activities for allocated team
Recruit, manage, coach and develop members of Data Management Operations
Ensure the consistent delivery of quality clinical trial data to Sponsors within the specified timeframe and be able to monitor the project budget, resource and implement cost control measures as appropriate
Ensure out of scope work is managed effectively. Keep senior management informed of all aspects of the project status
Ensure all data management documentation is consistent across a Sponsor’s project(s). Contribute to the preparation of documents and ensure relevant Sponsor and / or Cmed CRS Working Practices or Standard Operating Procedures are adhered too, and ensure Sponsor Satisfaction
Participate in significant Sponsor interaction; respond to Sponsor requests for information including presentations such as workshops and business planning meetings
Participate in, and support Business Development activities, i.e. bid defence meetings etc
Contribute to preparation and review of documentation to support Sponsor Request For Proposals
Actively promote and represent Cmed via attendance at meetings and conferences and as appropriate, become a member/involved with professional associations
Perform staff appraisals and conduct staff one-to-one meetings for line management staff
Assist and act as deputy for Local Head of Data Management Operations as appropriate
Ensure Data Management Operations Teams works in partnership with other Cmed line units
Contribute to, and implement, process and technical improvement efforts, monitor the outcome and recommend further action
Ensure timely and accurate entry of relevant study information and time recording occurs in the Management Information System (MIS)
Other tasks as assigned by Local Head of Data Management Operations.

Essential Work Experience and Qualifications

Degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience
Typically 8 or more years experience in drug development. At least 5 years in the discipline of clinical data management and 3 years in leading project teams

Attributes

Excellent organizational, planning, resourcing and leadership skills
Excellent interpersonal and communication skills and the ability to operate effectively in a global working environment
The ability to manage and coordinate staff/teams and delegate tasks
Professional, motivated and a positive attitude
Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process
Excellent negotiation, decision making and problem solving skills including risk analysis
Complete transparent approach, clear and precise
The ability to actively improve the effectiveness of the organization such as developing new processes, systems and customer relations
The ability to work effectively and efficiently with internal partners within Cmed

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[Full-time] Clinical Database SAS Programmer at CMED

2010-08-12 08:40:27

Location: Anywhere
Description:

Job Description

Job Title: Clinical Database SAS Programmer

Reports To: Team Leader of Clinical SAS Programming

Department: Database Configuration and SAS Mapping

Core Responsibilities

Principal responsibilities are to provide SAS software programming support for all data management activities performed by Cmed. Secondary responsibilities will involve support of maintenance and development of in-house SAS software tools to support database mapping and data management tasks.

Principal Accountabilities

Write and QC SAS software programs to map data exported from Timaeus database (as CSV files) to SAS datasets according to client specifications
Provide input as appropriate into specifications of data structures and Timaeus database applications to ensure adherence to the standards of the client or Cmed
Provide input as appropriate into database specification and CRF to ensure that both documents are consistent and adhere to the standards of the client or Cmed
Write and QC SAS software programs to generate appropriate listings (inc. patient profiles) and reports to support data management activities according to data management requirements
Provide all SAS software programming support to ensure timely and complete locking of clinical databases including importing randomisation data, import of third-party data, etc
Perform import and verification of data from client and provide transfer of deliverables from Cmed to client
Responsible for archiving of SAS software programs relating to data management support for assigned trials
Provide input to development of programs, processes and procedures and take part in/lead process initiatives as required by line manager
Provide input as appropriate into all meetings, discussions and activities covering all SAS software programming aspects for the assigned trials
Responsible for quality control and quality audit of SAS software programming deliverables
Maintain efficient and professional interactions with internal and external customers in consultation with Cmed management
Ensure timesheets are accurate and updated regularly
Maintain up-to-date knowledge of new developments/functionality of SAS software as new versions are released
Provide input to general departmental processes and procedures and take part in/lead process initiatives as required by line manager.

Essential Work Experience And Qualifications

Minimum of a BA/BSc or equivalent in computer science, mathematics, statistics, life sciences or related field(s)
Good working knowledge of SAS software (BASE, MACRO and GRAPH beneficial)
Knowledge/experience in clinical database design or data management
Minimum of 6 months experience in programming support for clinical trial management
Some knowledge of global clinical trial practices, procedures, methodologies

Attributes Include

Good organisational skills, plus an understanding of resource & budgeting
Good 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 good investigative and meticulous approach to all activities and tasks
Transparent approach, clear and precise
Team player
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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[Full-time] Systems Operation Manager (NJ) (Cmed Technology) at CMED

2010-06-17 09:29:37

Location: Anywhere
Description:

Job Description

Job Title: Systems Operation Manger (Cmed Technology)

Reports To: Global Head of System Operations

Department:

This position will be responsible for managing the Timaeus cloud to ensure zero downtime and high performance. It will be responsible for the local system operations team, in-house hosting and hosting at the third-party facilities located in the UK and US.

The System Operations Management will work closely with Cmed Technology’s research and development and quality assurance teams based in the UK and Romania to ensure new software releases are handed over to System Operations successfully. He or she will also work closing with Cmed Technology’s Customer Service organisation to ensure satisfactory Timaeus reliability and performance.

Core Responsibilities

The System Operations Manager will manage day-to-day systems operations of Timaeus, including:

Manage geographically-distributed team in the 24×7 operation of Timaeus
Manage Timaeus system operation (e.g., infrastructure installation and maintenance systems upgrades and decommissioning) within service level agreements (SLAs)
Manage response to and closure of tickets within internal and customer service level agreements (SLAs)
Routinely analyze performance and reliability, taking proactive measure to ensure ongoing scalability and performance
Manage interactions with external vendors for procurement, receipt, integration and/or operation (e.g., hosting) of technology infrastructure

Essential Work Experience and Qualifications

Bachelor’s degree Computer Science, Engineering or Information Systems (or equivalent industry experience)
Demonstrated experience managing enterprise-level systems using Ubuntu or RedHat Linux
Demonstrated experience managing enterprise-level systems using virtualization technologies (e.g., Xen, VMware)
Demonstrated experience automating enterprise system administration tasks using scripting languages such as Python and Bash
Experience designing, implementing, and maintaining large-scale web-based systems, i.e., systems with over 1,000 users and up-time exceeding 99.9%
At least one year of experience managing a geographically-distributed team of technology staff, including demonstrated experience budgeting and allocating staff time across at least three simultaneous projects
Strong communication skills, written and oral
Experience designing, implementing, and maintaining zero downtime systems.
Experience working within a regulated environment
Experience managing software-as-a-service- (SaaS-) based systems

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[Full-time] Graduate / Database Programmer I (NJ) (Cmed CRS) at CMED

2010-05-19 13:59:10

Location: Anywhere
Description:

Job Description

Job Title: Graduate / Database Programmer I (Cmed CRS)

Reports To: Principal Database Programmer

Department: Configuration and SAS Programming

Core Responsibilities

Configuration of Third Phase databases (screen design, visit definition and validation programming) to quality specifications and agreed delivery timeframes.

Principal Accountabilities

Creates screens, visit schedules according to annotated CRF and database specifications
Programs and tests validation checks (in Python) according to Data Management Plan (DMP) specifications
Programs routine third party data loaders (in Python) according to study requirements (routine loaders include generic lab data, ECG data)
Provides input as appropriate into all meetings, discussions and activities pertaining to Timaeus database configuration for assigned trials
Provides input as appropriate into specifications of data structures and database applications to ensure adherence to the standards of the client or Cmed
Provides input as appropriate into specifications of validation checks to ensure adherence to Cmed standards
Maintains professional interfaces with internal and external customers in consultation with Cmed management
Adheres to Cmed and/or project/study standards and database specifications
Develop Cmed and/or sponsor standards to allow rapid accurate database configuration
Maintains an up-to-date knowledge of new developments/functionality specific to database configuration of Timaeus as new versions are developed
Contributes to departmental processes and procedures and takes part in/lead process initiatives as required by line manager
Adheres to SOPs and WPs and ensures accurate and timely maintenance of documentation as required by such procedures
Ensures timesheets are accurate and updated regularly

Essential Work Experience and Qualifications

Degree in life sciences, computer sciences, pharmacy, nursing or nursing qualification (e.g. RN) or equivalent relevant experience. A lower qualification may be accepted provided this is supplemented with relevant additional experience
Exposure to concepts of clinical database applications and platforms with a knowledge of eDM and eDC processes
Foreign language skills would be advantageous..

Attributes

Good organisational skills, plus an understanding of resource & budgeting
Good 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 good investigative and meticulous approach to all activities and tasks
Transparent approach, clear and precise
Team player
Contribute to 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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[Full-time] Senior Clinical Data Manager (NC and NJ) (Cmed CRS) at CMED

2010-04-27 08:46:28

Location: Anywhere
Description:

Job Description

Job Title: Senior Clinical Data Manager (SCDM) (Cmed CRS)

Reports To: Team Manager

Department: Data Management Operations (DMO)

Core Responsibilities

Provide professional management and coordination of clinical trial data, on both an individual trial and project level (Phases I to IV). Identify errors and inconsistencies in CRF data and ensure their resolution in order that databases can be declared clean and locked according to ICH GCP standards.

Principal Accountabilities

Perform role of Clinical Data Manager (as outlined in Clinical Data Manager job description)
Ensure tasks documented in the study contract are completed on time and be able to assist monitoring the project budget and resource
Respond to requests made by the Sponsor for information or presentations such as workshops and project planning meetings as appropriate
Communicate effectively with the Sponsor via e-mail, telephone conferences, presentations etc in order to fully manage and lead the project or trial
Train, coach and mentor Clinical Data Associates I/II and Clinical Data Managers. Conduct departmental training workshops or presentations as required
Participate in, and support and Business Development activities, i.e. bid defence meetings etc
Actively promote and represent Cmed via attendance at meetings and conferences and as appropriate, become a member/involved with professional associations
Improve effectiveness of the organisation such as developing new processes, systems and Sponsor relations
Assist and act as deputy for Principal Clinical Data Manager or Data Management Operations Team Manager as appropriate
Ensure relevant Sponsor and / or Cmed CRS Working Practices or Standard Operating Procedures are adhered to
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

Degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience
Typically 4 or more years experience in drug development, at least 2/3 years in the discipline of data management
Foreign language skills would be advantageous.

Attributes

Very good organisational skills, plus an understanding of resource & budgeting
Very good interpersonal and communication skills and the ability to operate effectively in a global working environment
Work calmly under pressure and meet deadlines
Professional, positive, dynamic and driven
Thorough understanding of medical terminology, clinical trial methodology and ICH/GCP
Thorough level of understanding of physiology, pharmacology, clinical study objectives and the drug development process
A very good investigative and meticulous approach to all activities and tasks
Good negotiation and problem solving skills
Transparent approach, clear and precise
Demonstrate leadership by the ability to coordinate teams and delegate tasks to meet deadlines
The ability to work effectively and efficiently with internal partners within Cmed

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[Full-time] Principal Clinical Data Manager (NC and NJ) (Cmed CRS) at CMED

2010-03-27 16:37:44

Location: Anywhere
Description:

Job Description

Job Title: Principal Clinical Data Manager (PCDM) (Cmed CRS)

Reports To: Team Manager

Department: Data Management Operations (DMO)

Core Responsibilities

Provide leadership to subordinates, and professionally manage clinical trial data (Phases I to IV). Act as a consultant on the requirements for specific Sponsors to ensure that the data management is of the highest quality in order that databases can be declared clean and locked according to ICH GCP standards. Responsible for management of Clinical Data Associates I, II and Clinical Data Managers within DMO.

Principal Accountabilities

Perform role of Clinical Data Manager (as outlined in Clinical Data Manager job description)
Assist and act as deputy for Data Management Operations Team Manager
Participate in the recruitment of staff, specifically Clinical Data Associates I, II and Clinical Data Managers
Line Manage, coach, develop and provide leadership for Clinical Data Associates I, II and Clinical Data Managers
Train and mentor Clinical Data Associates I and II, Clinical Data Managers and Senior Clinical Data Managers. Conduct departmental training workshops or presentations as required
In conjunction with Data Management Operations Team Manager, ensure all tasks documented in the Sponsor contract are completed on time and be able to monitor the project budget, resource and implement cost control measures as appropriate. Ensure out of scope work is managed effectively. Keep management/senior management informed of all aspects of the project status
Respond to requests made by the Sponsor for information or presentations such as workshops and project planning meetings as appropriate
Communicate effectively with the Sponsor via, e-mail, telephone conferences, presentations etc in order to fully manage and lead the project or trial
Participate in, and support Business Development activities, i.e. bid defence meetings etc
Actively promote and represent Cmed via attendance at meetings and conferences, and as appropriate, become a member/involved with professional associations
Improve effectiveness of the organisation such as developing new processes, systems and Sponsor relations
Ensure relevant Sponsor and / or Cmed CRS Working Practices or Standard Operating Procedures are adhered to
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

Degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience
Typically 7 or more years experience in drug development. At least 4 years in the discipline of clinical data management and 2-3 years in leading project teams
Foreign language skills would be advantageous

Attributes

Excellent organizational, planning and resourcing skills
Excellent interpersonal and communication skills and the ability to operate effectively in a global working environment
Work calmly under pressure and meet deadlines
Professional, positive, dynamic and driven
Thorough understanding of medical terminology, clinical trial methodology and ICH/GCP
Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process
Excellent investigative and meticulous approach to all activities and tasks
Good negotiation, decision making and problem solving skills including risk analysis
Complete transparent approach, clear and precise
The ability to manage and coordinate staff/teams and delegate tasks
The ability to work effectively and efficiently with internal partners within Cmed

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

2010-03-26 13:09:04

Location: Anywhere
Description:

Job Description

Job Title: Head of Data Management (Cmed CRS)

Reports To: Global Head of Biometrics

Department: Data Management

Core Responsibilities

Oversee, direct and co-ordinate all activities and resources within Data Management Operations in the United States. To ensure high quality, timely and within budget management of DMO aspects of projects. To lead the development (with ROW colleagues) and execution (in US) of Data Management Operations strategy (incl the use of Timaeus by Cmed). To support and implement initiatives to improve/ change process for eDC and paper based Data Management Operations. To positively develop relations with clients and prospective clients. To work effectively with partners in Cmed.

Principal Accountabilities

All relate to DMO in the United States unless otherwise stated.

To direct the recruitment, management, coaching, development and co-ordination of DMO staff members
Ensure the consistent, timely delivery of quality DMO project deliverables to clients within the specified budget
Ensure Data Management Operations works in partnership with other Cmed line units, processes and partners to include, but not be restricted to, ROM">DMO, Configuration, Technology, IT, HR, Finance & MIS
In collaboration with UK and ROM (DMO) lead the creation and maintenance of SOP’s and working practices
Manage the effective use of resources and expertise within Data Management Operations
Lead the development and execution of Data Management Operations strategy in collaboration with Cmed Senior Management
Support business development activity and so contribute to the development and growth of business opportunities within Cmed
Ensure any DMO bid, including costings, resource calculation, is reviewed prior to being sent to client
Participate in professional association meetings as time permits
Other tasks as assigned by Line Manager

Attributes

Strong leadership skills
Global outlook
Excellent organizational, planning, resourcing and leadership skills
Excellent interpersonal and communication skills and the ability to operate effectively in a global working environment
The ability to manage and coordinate staff/teams and delegate tasks
Professional, motivated and a positive attitude
Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process
Excellent negotiation, decision making and problem solving skills including risk analysis
Complete transparent approach, clear and precise
The ability to actively improve the effectiveness of the organization such as developing new processes, systems and customer relations
The ability to work effectively and efficiently with internal partners within Cmed

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