$80K — $100K *
Who we are:
Over 525 PRA Biometrics resources currently in FTE Programs across 12 global clients
86% global team retention (well above industry standard)
Resources located in North America, South America, Asia-Pacific and Europe
Roles include embedded, dedicated leadership structure + all levels of Data Managers, Stats Programmers, Biostatistics, IVRS, ePRO, Medical Coding
Several teams are remote, others partially based in PRA Philadelphia headquarters, others at Sponsor sites, global PRA facilities
Management almost always grown from within, with a PRA manager in place for every team
Teams range in size from 1 resource to 200+ and several relationships have been established for 5, 10, and 15+ years!
Our motto: One client! One team! One set of processes to learn!
Provides data management oversight and accountability for one or more clinical trials.
Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
With the trial customer, CRO and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical data. – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.
Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
Takes a leadership role with the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met.
Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
Presents and trains at investigator and monitor meetings if needed
High school diploma with relevant experience required. Bachelor’s degree or equivalent in Health or Science discipline, with experience in clinical research, desired.
Minimum of 5 years of Data Management experience (start-up to lock).
Clinical trials experience is required. Experience managing multiples studies at once with experience managing competing priorities is needed.
Oncology experience is helpful. But, not required.
Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.
Project management skills. Must have prior experience creating timelines and managing deliverables.
Vendor management skills.
Advanced Microsoft Office skills including the ability to manipulate and analyze data.
Must have experience reviewing SAS and SDTM datasets.
Experience with RAVE is highly desired.
Highly organized with excellent written and verbal communication. Must have experience presenting during kick-off meetings, investigator meetings, and study team meetings.
Ability to interpret clinical trial data and present trends to clinical trial team on data.
Very minimal, if any, travel is expected. Possibly for investigator and/or kick-off meetings.
To qualify for a role located in the U.S., U.S. applicants must be legally authorized to work in the United States, and should not require now or in the future, sponsorship for employment work visa status.
Valid through: 5/7/2021
$100K — $150K
12 days ago