Senior Project Data Manager I
- United States
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
A Senior Project Data Manager I (SPDM I) is responsible for the data management project oversight resulting in quality and accuracy of the database for a clinical study. The SPDM I will perform as the Lead and is the primary DM contact for the project.
- Follow Standard Operating Procedures (SOPs).
- Act as Lead Data Manager for assigned data management projects.
- Coordinate the work of clinical data managers, clinical database programmers and medical coders assigned to the project.
- Train assigned Data Managers on project-related data management procedures and guidelines.
- Participate in hand-off, client study kickoff and closeout meetings.
- Create materials for and, if necessary, conduct internal kick-off meetings.
- Create materials for and, if necessary, conduct regularly scheduled meetings with the client, including creation of meeting agenda recording of meeting minutes.
- May have responsibility for the following Study Set-up tasks:
- Review draft CRFS/Electronic Case Report Forms (eCRFs).
- Prepare draft of CRF completion guidelines.
- Prepare draft management plan (DMP).
- Prepare Edit Check Specifications.
- Oversee/perform the UAT of the eCRFs/database, roles and edit checks.
- Review UAT findings and work with clinical database programmers to fix issues.
- Prepare Data Transmissions/Specification Agreements with external data vendors.
- Creation of project timelines.
- Ensure all project staff are trained and training documentation is retained for project team members.
- Preparation of Project Plan, including escalation pathway and project contact list.
- Review study reports for accuracy and consistency
- Communicate with the clinical database programming team regarding any database or programming changes needed throughout the study, when applicable.
- Oversee final QC review and data listing audits.
- Maintain and compile all study documentation.
- Perform steps pertaining to database freeze/lock and coordinate all related activities.
- Responsible for project budget oversight, revenue recognition and forecasting, billing and invoicing.
- Track study progress and issue periodic status reports.
- Create and manage study timelines and identify the achievement of key milestones such as draft or final database to the project team.
- Ensure project is audit ready.
- Identify data management project issues and alert Senior Department Management with a view to remedial action.
- Act as Project Manager on Biometric only projects.
- May create materials for and represent Clinical Data Management at Business Development related meetings.
- May assist in the creation of Business Development proposals by suppling data management related information and costs.
- Represent Advanced Clinical at professional meetings.
- Additional Responsibilities
- Assist in the creation and review of SOPs and training materials.
- Ad hoc report creation.
- Conduct training for employees.
- Interview job applicants and provide feedback.
- Perform other duties as requested by management.
Minimum Training Requirements:
- The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
- Applicable Standard Operating Procedures
- Good Clinical Practices (GCP Regulations' ICH Guidelines; Good Quality Practices)
- 21 CFR Par 11 and Computer Security (Part 11, Electronic Records; Electron Signature-Scope and Applications; 21 CFR 11 and Industry Guidance's; Computerized Systems Used in Clinical Trials)
- Good Clinical Data Management Practices
- Drug Development and Approval Process
- Data Management Overview
- MedDRA and WHODRUG Overview
- Sponsor/Study specific trainings, when applicable
- Applicable system training
Our Culture: https://careers.advancedgroup.com/embrace-our-culture
Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential
Community Programs: https://careers.advancedgroup.com/unleash-your-passion
For a complete list of all of our job openings, please visit Advanced Group's career site here .
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This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
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