Clinical Data Lead

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.

Clinical Data Lead

*EMEA based - remote working or office based*

*Candidates must be eligible to work within the EU*

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. 

• The point of contact for day to day activity on a study with key responsibilities for study  set-up  and close-out  tasks  as well  as overseeing  and coordinating  tasks delegated  to the study  team members  both  locally  and  in other  offices.
• Coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies.
• Reporting to the Project Manager I Sr. Project Manager, Data Management.

Overview of the Role

• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (approximately 10%) domestic I international.
• Read,  ensure   understanding  and  adhere  to  all  assigned   ICON/Client   SOPs  and  working procedures.
• Ensure all work performed is of high quality , compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
• Complete all assigned training (including the COL Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.
• Record all billable and non-billable time in the appropriate timesheet  management system  (e.g. Planview™).
• Independently prepare all materials and take part in study kick off (internal and external) meeting.
• Read, ensure understand ing and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study.
• Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst.
• Independently compile the change order log and distribute internally as per ICON's change order process.
• Demonstrate an understanding of the  revenue  recognition  and  revenue forecasting  process  by independently performing revenue recognition and revenue forecasting process on a monthly basis.
• Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.
• Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS).
• Lead development of the data management plan and study specific procedures.
• Ensure effective implementation of standard metric and status reporting on the study.
• Lead development of specifications for custom reporting on the study.
• Independently perform project planning tasks and develop the project plan and timelines.
• Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors.
• Adhere to ICON/Client SOPs, the Data Management Plan, Working procedures and study specific procedures in the implementation of tasks on the study.
• Adhere  to  the  project  plan  and  timelines  in the  implementation  of  study  tasks  during  set-up, maintenance and close-out of the study.
• Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components.
• Independently attend and provide an update for data management services at cross- functional study team meeting both internally and with the sponsor.
• Maintain and track meeting minutes, issues and decisions logs, and escalations.
• Independently negotiate the time lines and make study level decisions.
• Provide regular study status updates to the DMPM.
• Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is documented and the documentation filed in the Data Management Study files.
• Assess the training needs of study team members on an ongoing basis.
• Provide refresher training to team members as required.
• Provide feedback to the DMPM on issues with study team member performance .
• Deliver training to cross-functional study team members both internal and external (e.g. training in the study specific electronic CRF for monitors or Site staff at the investigatory meeting).
• Represent Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality Management System
• Participate in Business Development presentations to sponsor as required.

Role Requirements

• 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.
• US/LATAM/CAN: A minimum of 5 years clinical data management experience including 3 years' experience as a data management lead or point of contact for day to day activity on studies with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members.
• EU/APAC: Prior relevant clinical research industry experience.
• Experience of at least one of ICON preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
• Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project).
• Excellent communication and interpersonal skills, both verbal and written skills.
• Strong client relationship management skills and the aptitude to develop this further.
• Excellent  organizational  and  planning  skills  as  well  as  a  demonstrated  aptitude  for  project management, and the ability to lead more than one project and prioritize accordingly.

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 through the form below

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