Ref #: 27514

Employment type: Permanent - Full-Time

Location: Homebased

Description

Job Responsibilities

•Works closely with the corresponding Sponsor Data Management Operations Lead (DMOL) to ensure a seamless delivery of Data Management deliverables including holding regular status meetings with DMOL and other SMT team members as appropriate’
•Ensures study/ team deliverables are executed to expected quality and timelines, provides technical oversight as needed, and mentors/develops Clinical Data Management teams and other staff under the guidance of Manager / Sr. Manager, Data Management or designee.
•Fulfils his/her job responsibilities in accordance with Good Clinical Practices (GCPs),

ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), Study Specific Procedures (SSPs), Sponsor SOPs/WPs as appropriate, International Committee on Harmonization (ICH) Guidelines and applicable law and regulations.
Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.

•As a member of staff, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

•Read, ensure understanding and adhere to all assigned ICON and/or Sponsor SOPs and working procedures (as appropriate).
•Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
•Complete all assigned trainings and courses in the ICON Training Management system (iLearn) (and / or sponsor system, as appropriate); ensuring all mandatory courses are completed before the designated date.
•Read, ensure understanding and adhere to the study protocol, contract and scope of work for all tasks during set up, maintenance and close out of the study.
•Record all billable and non-billable time in the appropriate timesheet management system (as required).
•Lead the development of specifications, implementation and testing for the CRF.
•Lead the development of specifications, implementation and testing for the edit checks and data review listings.
• Lead the development of all other relevant Data Management specifications as required per process
• Ensure the effective implementation of standard metrics and ongoing status reporting on the study.
•Manage and provide leadership to local Data Management teams to ensure project objectives are met within budget and agreed timelines.
•Adhere to the Client/ICON SOPs, the Data Management Plan, Working Procedures and Study
Specific procedures in the implementation of tasks on the study.
•Support project management of activities in all locations, liaise with project/study teams, and escalate issues to local management and global study teams in a timely manner.
•Identify and clearly articulate DM risks and mitigation efforts, proactively applying contingencies wherever and whenever needed. Can identify the appropriate parties for escalation and can judge when to escalate further if needed.
•Provide resource projection and/or changes on an ongoing basis to Management as appropriate.
• Support and Mentor direct/indirect reports and extend technical expertise on an ongoing basis.
•Identify training needs and organize trainings as appropriate in coordination with ICON University and/or Sponsor.
• Identify process gaps and suggest process improvements (internal/external) on an ongoing basis.
•Develop, deliver and represent DM in internal and/or external presentations as required.
•Represent Data Management at internal / external / sponsor audits and manage findings through resolution both operationally and within the Quality Management System.
•Effectively manage work priorities of self and direct reports, delegating responsibilities where appropriate.
•Provide other general duties as required to support the company.
•Communicate effectively with internal and external stakeholders.
•Organise regular status meetings with sponsor DMOL and ensure any relevant actions and minutes are correctly recorded and followed up
•Reviews and contributes to preparation of protocols, Schedule of Assessments, Study Design and Data Management section.
•Participates in the development of training materials for Investigator Meetings and presents atInvestigator Meetings (if needed).
•Responsible for leading study start-up activities such as preparing the relevant set up documentation.
•Manages and Oversees all ongoing Data Review and tracking for all study related Data Management activities (including but not limited to clinical DB set-up, study maintenance activities- inclusive of all clinical data cleaning, generating study management/operational metric reports, and Clinical Database Lock)
•Leads and participates in the ongoing review of all data generated from the clinical study including central and local lab data, all other external data vendors, and coding.
•Leads and participates in the development and ongoing review of edit checks/listings for quality, content, format and output.
•Responsible for ensuring that clinical data is validated according to the relevant processes/study requirements and are ready for interim and final deliverables by providing clean and consistent data.
•Supports External Data Acquisition Specification development with Vendor and Clinical programmer as well as ongoing external vendor data transfers/review
•Supports eCOA (setup and ongoing data integration/review)
•Provides status updates/summarized metric reports to DMOL and SMTs and proactively identify and apply contingencies wherever and whenever needed
•Identifies and proactively communicates trends in the data and possible solutions for efficiencies
•Serve as the escalation point for unresolved data issues; collaborates with the Biogen DMOL, external data vendors, cross-functional team members to identify solutions
•Responsible for ensuring all relevant DM documentation is filed in the eTMF for their assigned trials
• Serves as the primary backup to the Biogen DMOL
•Regularly solicits feedback for enhancements to the data review guidelines from the DMOL/SMT (E.g. new or revised edit checks/listings)

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

•Relevant Clinical Data management experience.
• Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
•Knowledge of clinical trial database technologies and processes.
•s accountable and proactive in quality and risk management.
•Ability to liaise successfully with sponsors.
•Excellent written and oral communication skills.
• Excellent accuracy and attentiveness to detail.
• Capability to work within a team environment.
•Capability to manage competing priorities in a changeable environment.
•Capability to handle stressful situations and deadlines.
•Excellent interpersonal skills.
• 5 + years Clinical Data Management experience.
•Previous experience and proven competence in managing study delivery through full DM lifecycle
(planning, start-up, conduct, lock and closeout)
•Thorough knowledge of Data Review Process; E.g. SAE and external vendor data reconciliation, central and local laboratory data review, query writing and management, cross panel consistency checking, etc.)
• Comprehensive understanding of clinical development drug development process
•Proven ability to handle a high volume of highly complex tasks within a given timeline and demonstrate effective prioritization
•Able assess and communicate DM resource requirements


Physical Requirements and Work Environment:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•While performing the duties of this job the employee may be required to sit at a desk and utilize computer equipment for an extended length of time.
•The noise level in the work environment is considered quiet.
• Minimal travel may be required (less than 5%)


EDUCATION REQUIREMENTS
• Bachelor degree or local equivalent in a scientific and I or appropriate experience.