Clinical Data Lead

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

With our patients at the center 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.

**Location**:(Home-Based OR Office-Based)
- Mexico
- Colombia

**Overview of the Role**:
As a Clinical Data Lead (CDL) you will be 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. You will also co-ordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies.
- Independently prepare all materials and take part in study kick off (internal and external) meeting.
- Read, ensure understanding 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.
- Lead the development of specifications, implementation, and testing for the eCRF or paper CRF.
- Lead development of the data management plan and study specific procedures.
- 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.
- 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 negotiate the time lines and make study level decisions.
- 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.
- Travel approximately 10% domestic/international
- 5+ years clinical data management experience including 3+ years 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.
- 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
- Bachelors degree at a minimum

**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.**

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