Company: Cmed Group Ltd
Closing Date: 31 Jan 17
Type: Full Time
Salary (£): 30,000 - 40,000
Core Accountabilities: Provide leadership for tasks within CDM. As a functional lead has responsibility for the delivery of multiple, large or complex projects to high quality in accordance with Cmed’s contractual obligations and Standard Operating Procedures. May have responsibility for line management of Clinical Data Associates II and Clinical Data Managers.
1. Study Set-up
• Review and understand clinical trial documentation and, if appropriate, contribute to the preparation of documents such as the protocol
• Prepare or supervise the preparation of trial level documentation such as CRF completion guidelines,
Data Management Plan, validation check specifications, User Acceptance Testing (UAT) plans, reports and conventions necessary to ensure high quality and consistent data
• Set up and maintain accurate trial documentation and filing systems to ensure safe and secure storage of data and documentation
• Provide input into eCRF/CRFs, clinical trial database design and validation check programming
• Perform or supervise the performance of all database setup activities to ensure the release of quality databases according to sponsors’ expectations, study budgets, clinical trial documentation and timelines
• Ensure the implementation of the guidelines across the trial is consistently adhered to
2. Study Management
• Take a lead role and act as the main Sponsor contact for CDM activities on assigned trials.
Responsibilities of if this role include:
• Ensure on-going data processing (data review Serious Adverse Event reconciliation, clinical coding, third party data management) is performed across the Data Management project team achieving to expected quality standards.
• Maintain accurate study statuses and ensure all relevant individuals, e.g. Senior Management and /or Sponsors are regularly updated, with appropriate and timely issue escalation
• Proactive workload planning, forecasting and project resourcing to achieve successful, timely key deliveries
• Ensure all tasks documented in the Sponsor contract are completed on time and actively monitor the project scope, budget, resource and implement cost control measures
• Provide Clinical Investigational Trial Site/Sponsors’ staff study specific eCRF training and provide ongoing support to site
• Communicate effectively and proactively with the Sponsors via e-mail, telephone conferences,
Presentations, workshops etc. in order to fully manage and lead the project or trial.
• Adhere to relevant Sponsor and / or Cmed CRS Standard Operating Procedures and policies.
• Line manage, develop and provide leadership for Clinical Data Associates II and Clinical Data Managers and conduct performance reviews and one-to-one meetings
• Train, coach and mentor Clinical Data Associates II, Clinical Data Managers and Senior Clinical Data Managers.
• 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 the effectiveness of the organisation by taking a lead role in and contributing to departmental processes and technical improvement efforts
• Assist and act as deputy for Manager, Clinical Data Management or Associate Director as appropriate.
• Ensure timely and accurate entry of study information in the time recording system
• Define and deliver training workshops or presentations within Biometrics including the management of assigned Technical Training Modules (TTM) and associated competency assessments.
• Prepare for, participate in and respond to capability, internal and external audits
The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
Essential Work Experience, Qualifications and Knowledge:
• Degree level qualifications or equivalent experience
• Advanced knowledge of database design, structures and handling data from external sources
• Experience in the discipline of clinical data management especially leading EDC studies
• Extensive experience in leading data management studies (in particular EDC)
Desirable Work Experience, Qualifications and Knowledge:
• Performed lead data management duties within a Contract Research Organisation
• Understanding and managing of study budgets
• Basic knowledge data review tools for example Cognos, SAS viewer
• Experience in line management
Cmed Core Values:
All Cmed employees are required to exhibit and demonstrate the Cmed ‘Core Values’.
• Client focus: Satisfaction and Solutions
• Dependability: Competence and Quality
• Trustworthy: Open and Honest
• Innovative: Approaches
• Winners: Win-Win
Planning and Organisational Skills:
• Excellent planning, prioritisation and organisational skills and rational and balanced management of resources and budgets
• An excellent investigative and meticulous approach to all activities and tasks
Communication and Teamwork:
• Excellent interpersonal and communication skills and the ability to operate effectively in a global working environment
• Ability to work calmly under pressure, managing multiple Data Management project teams to achieve deadlines
• Transparent approach, clear and precise
• Professional, positive, dynamic and driven
• Demonstrate leadership and accountability by the ability to identify and organize resources as needed to achieve project goals
• Ability to motivate, mentor, lead and delegate tasks to line or project teams Technical
• Ability to perform the role of a Data Management functional lead on multiple projects, from database setup to lock, efficiently and to a high standard
• Thorough understanding of medical terminology, clinical trial methodology and ICH/GCP and other regulations
• Thorough level of understanding of physiology, pharmacology, clinical study objectives and the drug development process
• Advanced negotiation and problem solving skills
• Eagerness to learn and develop and promote new skills
Holmwood Broadlands Business Campus Langhurstwood Road Horsham
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|Fax:||+44 (0)1403 755051|
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