Apply relevant components of the project protocol to daily tasks and guide others on their application.
Serve as an interdepartmental and client liaison for all data management study activities.
Produce project-specific status reports for management, Project Lead, and/or clients regularly.
Monitor and analyze study metrics; escalate per the organization's risk management processes.
Participate in business development activities, including bid preparation and representation at bid defense meetings when required.
Assist with project forecasting of hours and identification of resource requirements.
Support oversight of project budgets, including identifying potential out-of-scope work and participating in the Contract Modification process.
Lead high volume/highly complex studies, delegating tasks to ensure timely completion of project activities within project, quality, and budget requirements.
Mentor junior staff on all study-associated tasks.
Assist with administrative and financial oversight for allocated projects.
Communicate regularly with management regarding data management progress and challenges.
Qualifications
Bachelor's degree (BS) or equivalent, with relevant formal academic/vocational qualification.
5+ years of relevant experience providing the knowledge, skills, and abilities to perform the job.
Knowledge, Skills, and Abilities
Strong understanding of CRF, CDISC, Clinical Data Management, GCP (Good Clinical Practice), and ICH Regulations.
Proficiency in Veeva Vault and other data management platforms.
Ability to effectively apply knowledge and skills in a highly organized manner while adhering to regulatory guidelines, SOPs, and client expectations.
Proficient in interactive computer programs and clinical data management tools.
Excellent written and verbal communication skills, with strong command of English grammar.
Strong organizational, analytical, and problem-solving skills with exceptional attention to detail.
Ability to work both independently and collaboratively in a team environment.
Demonstrated ability to maintain strict confidentiality with clinical and client proprietary data.
Proven capability to act as a study or departmental expert for data management processes.
Skilled in project resourcing, timeline planning, and ensuring adherence to project schedules.