What the Senior Clinical Data Manager does at Worldwide

Oversee, lead, manage and provide technical expertisewithin the assigned projects to ensure that they are executed in an efficient, accurateand timelymanner to the Sponsor’s satisfaction. 

What you will do

• 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 tomonitor the progress 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.

What you bring to the role

• 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.

Your experience

• 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.