Senior Clinical Data Manager

Worldwide Clinical Trials•Virtual United States North Carolina, NC

1d•$79,000 - $157,000

About The Position

We are a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. 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. Join us!

Requirements

Excellent attention to detail
Excellent written and verbal communication skills
Strong knowledge of data management best practices and 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 processes, protocol documents (protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), study reports), and related procedures
Strong analytical and problem-solving skills
Independent and autonomous project oversight skills
Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience
Minimum of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries

Responsibilities

Oversee, lead, manage, and provide technical expertise within assigned projects to ensure they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction.
Provide fully independent and autonomous leadership of data management services (start-up, conduct, and closeout) across multiple complex global projects/programs.
Ensure appropriate resources are allocated to complete all data management (DM) activities on time and within budget.
Prepare DM trial documentation, including Data Management Plans (DMPs), Database Specifications, Edit Check Specifications, CRF Completion Guidelines (CCGs), and Data Transfer Agreements (DTAs).
Ensure effective User Acceptance Testing (UAT) is performed.
Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, Interactive Response Technology (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 Clinical Trials Data Management 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 outstanding issues (e.g., during Project Review Meetings).
Collaborate with internal Worldwide Clinical Trials departments working on the same project.
Provide feedback on process improvements to DM Management and/or Subject Matter Experts (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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.