Process Data Manager (REF6722Y)

Job Description

TheProcess Data Manageris responsible for managing data entry projects in the GXP and non-GXP data entry system. This positionwill be responsible for applying digital office tools, data management, and project management fundamentals to facilitate data entry activities. The Process Data Manager is expected to familiraize themselves with all aspects of department operations and identify further opportunities to use automation or other tools to reduce unnecessary or repetitive work.

Essential Functions Include:

• Maintaining and tracking data entry assignments for data enterers for manufacturing, raw material, batch disposition, and other data.
• Act as the lead for projects, assume responsibility for completion of tasks by due dates, and managing workload of team members on projects.
• Ad-Hoc data entry, collection, or verification may be required to complete projects or assignments.
• Perform data corrections in the database as needed.
• Effectively communicate with other system owners to update original source data if necessary.
• Review compliance instances for impact to data in database.
• Maintain spreadsheets, automate tasks using digital office tools and other systems, and monitor metrics.
• Participate in Compliance Activities such as initiating and completing NOEs, EOEs, CAPAs, or other instances as needed for projects or data management.
• Complete audits of the data entry system per procedure and write a monthly technical report detailing the audits and database activities for each reporting period.
• Obtain specific assignments from ProPharma Group or client Project Manager.
• Ensure individual activities are clearly communicated and documented to Project Manager.
• Review assigned protocols prior to execution.
• Perform technical writing and communicate clearly on all technical, business, and professional interpersonal levels of the organization.
• Attend and contribute to scheduled Practice meetings.
• Participate in company programs such as Project Management, Quality, Social Responsibility, Wellness, Safety and Training.
• Create annual personal goals and development plan with administrative manager.
• Other duties as assigned.

Qualifications

Qualified candidates must have:

• B.S./B.A. in Engineering, Life Sciences, or a related field. An undergraduate degree from an accredited university is required.
• Minimum 1-year experience in the field of Process Data Management.
• Minimum 1-year experience in related Pharmaceutical or Healthcare Industries.
• High attention to detail and ability to verify large data sets or work in large data sets or databases accurately required. Ability to review system audit trails a plus.
• Interpersonal skills required to work with team to complete projects and assignments to meet deadlines. People management skills a plus.
• Ability to use currently available tools for managing moderate size spreadsheets (e.g., power query, macros).
• Technical writing skills required. Ability to write technical reports or investigations.
• Individuals with project management experience preferred.
• Possess effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• General business math skills.
• Working knowledge of Microsoft Word, Microsoft Excel, and other word processing programs as may be required by the position (PowerPoint, Access and Microsoft Project may be required) including but not limited to Visio.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field, read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
• Basic knowledge of FDA GxPs, FDA Guidelines, and European Guidelines (where applicable) and other regulatory requirements.
• Basic knowledge of industry best practice such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
• Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements.

Additional Information

• All candidates must be legally eligible to work in the United States
• Client is unable to provide relocation for this project opportunity
• We are an equal opportunity employer. M/F/D/V
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.