Ref #: 28079

Employment type: Permanent - Full-Time

Location: Homebased


The Outsourced Data Management Operations Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) development to Clinical Study Reporting (CSR) of Clinical Data) and ensures timely project execution, quality data deliverables, and prioritization of all DM milestone delivery. Recognized as the DM operational specialist in clinical data flow and study execution by all functions within their assigned SMTs.

Is managed and directed by DOCS Line Managers and supports DOCS initiated internal process improvement initiatives. The Outsourced Data Management Operations Lead will not be assigned to support sponsor internal process improvement initiatives and will not attend sponsor company internal events and/or town hall meetings.

•By acting as the primary Data Management (DM) representative to the study management team, the Outsourced DM Operations Lead partners with Sponsor Data Management Portfolio Lead and other key study/program team members to implement project plans for assigned studies, ensuring the functional activities are completed by external data vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with external data vendors to support the flawless execution of a clinical trial.
•Uses phase, TA and operational knowledge to establish and implement study level operational plans and oversees vendors to ensure on time project delivery on all assigned projects.
•Develops study level quality/oversight plans and ensures adherence and consistent execution across the data flow. Collaborates with sponsor DM Portfolio Leads to ensure alignment of study operational plans with program goals. Contributes to and/or accountable to update and manage study dashboards, timelines, resource prioritization, and data deliverables.
Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
•As a member of staff, the ICON DOCs 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).
•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 ICON DOCS 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 study specific presentations as required.
•Participate in internal / external / sponsor audits of assigned studies and manage findings through resolution both operationally and within the Quality Management System.
•Effectively manage work priorities of self and indirect reports, delegating responsibilities where appropriate.
• Provide other general duties as required to support the company.
•Communicate effectively with internal and external stakeholders.
• Participates in the development of training materials for Investigator Meetings and presents at
Investigator Meetings (if needed).
•Responsible for ensuring all relevant DM documentation is filed in the eTMF for their assigned trials

Accountable for development of timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and external data vendors on assigned studies:

o Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees supporting DM personnel, and monitors and reports on overall study progress.
o Accountable for quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
o Develops risk mitigation or action plans and oversees execution when appropriate.
o Reviews performance metrics and trends for DM deliverables on assigned studies/programs
and ensures most optimal execution. Reports/Escalates issues/risks to Sponsor Portfolio
o Primary contact between DM and clinical study management teams (SMT). Liaises directly with stakeholders (Biometrics functions, Clinical, Medical, Regulatory Affairs)
o Manages performance and quality issues with external data vendors (3rd party data providers such as labs) and escalates to sponsor DM Portfolio Lead and DM management. Develops appropriate risk mitigation, as needed
o Support study-level/drug program audit and inspection readiness activities as needed
o Inputs/Develops timeline and project manages all end to end data deliverables for assigned
studies and tracks & reports progress at relevant forums
o Accountable for overall quality and integrity of study data and ensures in-stream data cleaning approaches are implemented for the studies.
o Manages performance and quality issues with external data vendors and develops appropriate risk mitigation as needed.
o Approves study timelines and operational plans
o Makes daily decisions regarding study processing.
o Prioritization of multiple competing tasks and timelines
o Negotiating with and leading change within a cross functional team of peers
o Organizes and Oversees work across multiple stakeholders to meet study timelines

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.

• 5 + years 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.
• Is 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.
• Previous experience and proven competence in managing study delivery through full DM lifecycle
(planning, start-up, conduct, lock and closeout)
• Deep understanding of drug development and biopharmaceutical industry required
• Robust experience with Medidata Rave and use of Data Review tools such as J-Review or Business
Objects required
•Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
• High attention to detail including proven ability to manage multiple, competing priorities
• Experience working on outsourced clinical trials
• Experience developing and implementing DM process and data standards
•Demonstrated ability to establish effective business process and relationships with external stakeholders, including implementing process change
•Demonstrated ability to influence without authority

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 10%)

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