Senior Clinical Data Manager – Medical Device

📋 Description

• Lead data management on studies and take charge of developing project documentation, system setup, data entry, and data validation procedures for less experienced staff.

• Take responsibility for all data management activities (from study start-up to database lock) in accordance with client quality standards, adhering to project timelines and budgets.

• Serve as a subject matter expert (SME) for data management activities during relationship meetings with Sponsors.

• Collaborate directly with Sponsors to grasp their specific requirements and drive the implementation of those needs.

• The Senior Clinical Data Manager will partner with the leadership team to offer guidance, mentoring, and training to the data management team, ensuring the adoption of optimal working practices.

⛳️ Requirements

• University or college degree.

• Relevant work experience or education equivalent to a bachelor's degree will be considered in lieu of a bachelor's degree (Fortrea may recognize relevant experience as an alternative to educational qualifications).

• Proficient in English, both spoken and written, as this role involves client interactions.

• A minimum of 5-7 years of experience in clinical data management is required.

• At least 3 years of hands-on experience with clinical EDC systems is essential.

• Comprehensive understanding of the clinical trial process, data management, clinical operations, biometrics, and system applications supporting operations.

• Demonstrated ability to lead by example in project strategies and achieve departmental goals, objectives, and initiatives, while motivating team members to seek solutions.

• Familiarity with the relationship and regulatory obligations of the CRO industry in relation to pharmaceutical, biotechnological, or medical device companies.

• Strong time management skills with the ability to meet project productivity metrics and deadlines.

• Capability to work collaboratively in a team environment and engage with colleagues.

• Proficient in mentoring junior department members, providing SME insights on data management practices.

• Excellent organizational skills, along with strong communication and interpersonal abilities.

• A constructive problem-solving attitude, focused on deadlines amidst time constraints, incomplete information, or unforeseen events.

🏝️ Benefits

• Potential for travel to provide cross-site support or training needs,

• up to 10% of the time,

• with as much as 50% of that time requiring overnight stays.