Project Data Management, Data Acquisition Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for overseeing project management of all data management services for designated projects.

• Ensures that the contracted Non-CRF Data Management activities for projects are executed by the Company in line with the signed contract and the Sponsor’s expectations.

• Serves as the Functional Lead for Data Management, acting as the main point of contact for internal coordination between Data Management/Operations, Project Management, Clinical Monitoring, and other functional teams.

• Organizes the efforts of the assigned Data Management/Data Operations team.

• Communicates independently, proactively, and clearly with internal and external stakeholders, showcasing the ability to work autonomously on the non-CRF data strategy for the study team.

• Takes ownership of non-CRF data.

• Conducts a thorough assessment to identify all non-CRF data types as defined in the study protocol through protocol review and team discussions (including amendments).

• Aids in the implementation of the patient enrollment and randomization strategy, responsible for the setup of IXRS UAT.

• Implements, maintains, and approves non-CRF Vendor Transfer Agreements/plans/specifications.

• Verifies that non-CRF vendor specifications can be fulfilled and provides expertise on testing/results.

• Effectively communicates non-CRF data collection deliverables, work status, and data issues to the Client study lead and other team members.

• Coordinates cross-functional non-CRF tasks with a strong understanding of downstream processes and stakeholder needs and impacts.

• Receives, processes, and delivers non-CRF test and production data.

• Ensures the initiation, delivery, and completion of all Data Management activities and milestones in accordance with the contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.

• Provides project-specific training to both internal and external audiences as needed.

• Oversees financial management of assigned projects/programs, including revenue recognition, scope changes, and participation in internal project review meetings, collaborating with Finance and Contracts groups as necessary.

• Monitors and communicates project progress to the Sponsor and project team, utilizing project status reports and tracking tools/metrics to facilitate in-stream data collection and query management.

• Plans, manages, and requests resources for assigned projects.

• Develops and maintains project plans, specifications, and documentation in accordance with SOP requirements.

• Keeps documentation current and ensures that all TMF filing is complete and up to date.

• Participates in and presents at internal, Sponsor, third-party, and investigator meetings.

• Plans for and creates necessary documentation to support internal and external audits, and participates in such audits.

• Trains and mentors data management staff.

• Prepares input for and takes part in proposal bid defense meetings.

• Maintains proficiency in Data Management systems and processes through regular training.

• Performs additional work-related duties as assigned.

⛳️ Requirements

• BA/BS in biological sciences or related disciplines in the natural sciences/health care field or a Registered Nurse.

• A minimum of 8 years of experience in Clinical Data Management.

• At least 3-4 years of experience in external vendor data setup and non-CRF setup activities.

• Experience with DTS (Data Transfer Specification), DTA (Data Transfer Agreement), and FFS (File Format Specifications).

• Familiarity with eCOA, ePRO, patient diaries, device testing, sensor testing, data transfer agreements, external data setup, labs, ECG, and IWRS/IVRS testing.

• Knowledge of Clinical Data Management practices and relational database management software systems.

• Strong project management skills and understanding of project management methodologies.

• Proven staff leadership abilities.

• Experience in a Contract Research Organization (CRO) is preferred.

• Direct exposure to Oracle Clinical, Rave, or Inform systems.

• Understanding of medical terminology, clinical data, and ICH/Good Clinical Practices.

• Proficiency in MS Windows navigation, as well as Word, Excel, PowerPoint, and email applications.

• Excellent oral and written communication skills.

• Strong presentation abilities.

• Good organizational, planning, and time management skills, with the capacity to multitask under tight deadlines while maintaining attention to detail.

• Ability to be adaptable and flexible, working independently and as part of a multidisciplinary team.

• Capability to make effective decisions and manage multiple priorities in a fast-paced environment.

🏝️ Benefits

• We are dedicated to nurturing our employees through career development and advancement opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive total rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.