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Job Details

Lead Clinical Data Manager – Contract (with potential for permanent position) - Can be based anywhere in the UK (home based)

Company: Clintec
Location: Home based
Reference: UK-LCDM-301017-MC
Closing Date: 20 Dec 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

The Lead Clinical Data Manager will be responsible for setting up an Oncology study and the day-to-day operational activities of clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements.  

Requirements:

Role Purpose

The Lead Clinical Data Manager will be responsible for setting up an Oncology study and the day-to-day operational activities of clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements.  This activity is coordinated in conjunction with one or more vendors and, where appropriate, Clinical Operations staff. Mentoring and support of junior Clinical Data Management staff as expected.

Key  Accountabilities:

  • Set up and Oncology trial in the UK
  • Act as Lead Data Manager for assigned studies.
  • Accountable for timely deliverables of all DM activities of their assigned projects
  • Projection and management of Data Management study timelines
  • Tracking of billable hours for the DM team against the budgeted hours
  • Flag resourcing needs to the Team Lead as and when required
  • Track and Monitor KPIs for their assigned studies.
  • Complete project trend analysis of all issues flagged in the issue tracker for their assigned studies and discuss with the team to achieve quality data
  • Ongoing internal oversight of study status and update the status tracker regularly and report to management periodically.
  • Responsible for timely completion and quality of the study start up documents like eCRF/CRF design, aCRF, Data Management Plan, Data Validation Plan, eCRF completion guidelines etc. as applicable.
  • Responsible for study set up of Clinical Data Management System (CDMS), and ensures completion of systems and tools to enable successful trial execution and reporting
  • Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy. This will include reviewing and resolving all discrepancies.
  • Ensure third party recon are delivered as per required quality and timelines for their assigned studies
  • Track and Monitor the discrepancy status for their assigned studies to ensure quality and timely deliverables.
  • Track and Monitor the SAE recon and Medical Coding status for their assigned studies.
  • Perform Medical Coding activity for assigned studies as applicable.
  • Perform close out activities for their assigned studies.
  • Accountable for timely deliverables of all DM activities of their assigned projects

Communication:

  • Maintains regular internal contact with relevant stakeholders such as Project Management, Medical Writing, Statisticians and others as necessary.
  • Attend meetings for project kick-off; investigator meetings, assuring investigators and site coordinators are well trained on the study; and attending project team meetings throughout the study.
  • Responsible as the primary contact with the sponsor/vendor in managing protocol execution

Training & Compliance

  • Create CAPA and root cause analysis for assigned studies as applicable.
  • Ensure audit readiness for their studies
  • Participates in innovation and process improvement initiatives.
  • Train the Internal staff on the study protocol, ensuring that staff understand the study set up and validation procedures
  • Mentor and support the junior data management staff as required.
  • Provides input for definition of new or revised process development, problem solving, training, etc.as needed.
  • Undergo training on study protocols and other DM related documents as applicable and ensure data cleaning is performed to the highest standard
  • All assigned tasks are compliant with Standard Operating Procedures (SOPs), ICH-GCP and other applicable guidelines.
  • Ensure compliance to trainings as per the training plan approved by the Line Manager

 

EDUCATION/EXPERIENCE/SKILLS:  

  • Degree in related discipline and eight years of related experience; or,
  • Equivalent combination of education and experience.

Experience:

  • In depth knowledge of CDMS systems such as RAVE with study set up and database lock experience
  • Proven experience as a Lead Data Manager on large global projects

Knowledge/Skills/Abilities:

  • Knowledgeable in Good Clinical Practice requirements
  • Extensive clinical research knowledge and cross-functional understanding of other operational departments
  • Organizes and prioritizes numerous tasks and completes them under time constraints.
  • Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques.
  • Resolves a wide range of issues in creative ways.


JOB COMPLEXITY:

  • Performs job duties with minimal / no guidance from the Manager
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
  • Networks with senior internal and external personnel in area of expertise.

 

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package. 

Apply for this job: Lead Clinical Data Manager – Contract (with potential for permanent position)  - Can be based anywhere in the UK (home based)

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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