Senior Clinical Data Manager
SUMMARY:Oversee, lead, manage and provide technicalexpertisewithin the assigned projects to ensure that they are executed in an efficient, accurateand timelymanner to the Sponsor’s satisfaction. RESPONSIBILITIES:
- Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex globalprojects/programs, including:
- Ensureappropriateresourcesare allocatedto 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 tomonitorprogress of trial activities.
- Ensure alldatabaselock activities are completed on time.
- Represent WorldWideDM 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 Worldwidedepartments working on the same project.
- Provide feedback on process improvements to DM Management and/or SMEs.
- Participate in and lead process reviews.
- Provide training,supportand mentorship to other members of the DM department.
- Participate as necessary in sponsor audits, regulatory authority inspections and otherthird partymeetings.
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. OTHER SKILLS AND ABILITIES:
- Excellent attention to detail.
- Excellent written and verbal communication skills.
- Strongknowledge of data management best practices & technologies as applied to clinical trials.
- Excellent communication and interpersonal skills to collaborate with cross-functionalinternal and external teams.
- Strongunderstanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Stronganalytical and problem solving skills.
- Independent and autonomous project oversight skills.
REQUIREMENTS:
- Bachelor’s degree or higher in biomedical sciences, life sciences, computerscienceor 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.
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. 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 ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.