Ref #: 28965

Employment type: Permanent - Full-Time

Location: United States - remote

Posted: 01-Nov-2021


ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

The Senior Data Management Operations Lead manages 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.

-Acts as a mentor to less experienced DM peers and vendor data management team members, possesses strong knowledge of DM trial execution processes, manages complex trials, and is recognized as a DM process subject matter expert.
-Develops study quality plans and ensures adherence and consistent execution across the data flow and within programs.
-Contributes to and/or accountable to update and manage study dashboards, timelines, resource prioritization, and data deliverables.
-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:
-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.
-Accountable for quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
-Develops risk mitigation or action plans and oversees execution when appropriate.
-Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Sponsor Portfolio Lead.
-Primary contact between DM and clinical study management teams (SMT). Liaises directly with stakeholders (Biometrics functions, Clinical, Medical, Regulatory Affairs)
-Is recognized as a Subject Matter Expert for DM process, data collection and management, and reporting
-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.
-Support study-level/drug program audit and inspection readiness activities as needed
-Coordinates timelines, data deliverables and priorities across multiple studies and phases within a program or therapeutic area for all dataflow activities
-Accountable for implementing consistent operational and quality plans across multiple studies within a program and for the delivery of the overall quality of study data
-Manages performance and quality issues with external data vendors and develops appropriate risk mitigation as needed by analysing and trending vendor performance across multiple studies and phases
-Develops and Approves timeline and project manages all end to end data deliverables for assigned studies and tracks & reports progress at relevant forums
-Implement collection standards for studies ensuring consistent application across a program
of studies and educates individual SMTs on how decisions applied to one study affect the final consolidated data used for integration and submission
-Trends risk and mitigation plans for each assigned study and consolidates information to provide study status for senior management and sponsor DM Portfolio Lead

To be successful in the role, you will have:
-Bachelor's degree
-5 + years 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 at a vendor

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.