Senior Clinical Data Manager

Worldwide Clinical Trials • Durham, NC

2d

About The Position

Oversee, lead, manage and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction. This role involves providing fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects / programs.

Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
• Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
• Excellent attention to detail.
• Excellent written and verbal communication skills.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Excellent communication and interpersonal skills to collaborate with cross- functional internal and external teams.
• Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Strong analytical and problem solving skills.
• Independent and autonomous project oversight skills.

Responsibilities

• Ensure appropriate resources are allocated to complete all DM activities on time and budget.
• Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
• Ensure effective UAT is performed.
• Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).
• Oversee data cleaning activities.
• Produce metrics to monitor progress of trial activities.
• Ensure all database lock activities are completed on time.
• Represent Worldwide DM at both internal and external study meeting calls, including providing input.
• Monitor project scope, budgets and risks and alert DM Management of any concerns.
• Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g. during Project Review Meetings).
• Collaborate with internal Worldwide departments working on the same project.
• Provide feedback on process improvements to DM Management and/or SMEs.
• Participate in and lead process reviews.
• Provide training, support and mentorship to other members of the DM department.
• Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings.
• Perform other duties as assigned.

Benefits

• We believe everyone plays an important role in making a world of difference for patients and their caregivers.
• From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed.
• We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.
• We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.
• We love knowing that someone is going to have a better life because of the work we do.
• We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.
• We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.
• We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior