Senior Clinical Data Manager
Who we are
We’re 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.
Why Worldwide
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!
What the Senior Clinical Data Manager does at Worldwide
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.
What you will do
- 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.
What you bring to the role
- 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
Your experience
- 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
- Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
United States of America - $79,000.00 - $157,000.00
The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.