Clinical Data Lead

As a Lead Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

The Data Manager (DM) is responsible for conducting related data management activities on CEP clinical trials from extended synopsis to study archiving by establishing study specific planning, ensuring activities are conducted in agreement with timelines and according to current SOPs, guidance, standards, acting as data management representative in the clinical study team and collaborating as required with external groups. He/she is the global data management contact within a compound, responsible to ensure consistency and good communication across the studies. The DM participates in working groups to develop and implement new processes, tools and procedures. The job may include international responsibilities.

• Primary contact between CEP Clinical Operations and clinical study teams.
• Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies, in particular builds a strong collaboration with the study CTM.
• Negotiates responsibilities and timelines.
• Ensures external functions (i.e., Coding, CRF design, DB design, DB support) are consulted appropriately on study decisions.
• Implements and oversees processes and coordinates activities in conjunction with the study team and Associate DM (if applicable).
• Proposes solutions for data management issues that arise during the conduct of a study.
• Responsible for product level activities.

Additional responsibilities:

• Conducts Data Management activities in agreement with current regulations, procedures and technologies
• Manages database design implementation (develop CRF specifications, Review and validate the database design and edit checks in collaboration with Technology&Information Management support group)
• Participates in the programming of the Data review and surveillance report -
• Manages data cleaning (Ongoing data validation, DRF management…) -
• Loads external data (when applicable) -
• Performs external data reconciliation (e.g PK, SAE.. when applicable) -
• Manages database closure (coordinates data coding/data review, leads pre-lock meeting, conducts database closure, Assess CRO, files study related documents…)

You are:

• Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts preferred.
• High level of knowledge in the use of Data Management applications and database/file structures; able to use SQL, SAS and other programming/query languages; able to acquire and apply new technical skills.
• Knowledge of industry standards and practices.
• Aware of the clinical development process.
• Communicates effectively with study teams and departmental associates.
• Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic.
• Detects problems, issues, and delays quickly, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results.
• Consistently meets deadlines according to accepted levels of quality, paying attention to details.
• Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion.
• Sets clear assignments as well as clear objectives and measures; monitors process, progress and results.
• Project Management skills
• Ability to prioritize activities Good level of English if second language.

US: Bachelor degree, preferably in a life science or mathematics-related area (e.g. computer sciences) and/or with 8+ years industry experience with at least 2 years of clinical data management experience.
Oral and written communication skills.

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.