Senior Clinical Data Lead

hace 4 semanas

Bogota, Colombia ICON plc A tiempo completo

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.

We have an incredible opportunity for a **Senior** **Clinical Data Lead** to join the team.

**Location**: home-based OR office-based
- Mexico
- Colombia

**Overview of the Role**:
As a Senior 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 coordinate 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 meetings (internal and external)
- 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 (DMP), study specific procedures, and specifications for custom reporting on the study
- Independently perform project planning tasks, develop the project plan and timelines, and independently negotiate the timelines and make study level decisions
- Act as a key point of contact for the sponsor and the study team
- Delegate data review, data reconciliation, and query management tasks and review and ensure the quality of the work completed
- Act as a mentor to all junior staff levels
- Proactively identify risk, manage risk, and inform appropriate parties
- Be familiar with costing tools and provide support to PM for change orders and unit tracker updates
- Effectively solve problems by leveraging expertise and seeking information effectively from other parties where needed
- Travel (approximately 10%) domestic and/or international

**To be successful, you will need**:

- 5+ years of clinical data management experience (in a Clinical Research Organization or Pharmaceutical company)
- 3+ years of experience leading studies with key responsibilities for study set-up and close-out tasks
- Experience with at least one of ICON’s preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
- Highly computer literate, including strong Microsoft Office skills
- Excellent communication and interpersonal skills
- Strong client relationship management skills
- Excellent organizational and planning skills as well as a demonstrated aptitude for project management
- Bachelor’s degree or local equivalent in a scientific field and/or appropriate experience

**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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