Who are we?
We Are PRA.
We are over 15,000 employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most. Come join the movement and discover YOUR PRA.
Who are you?
You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Lead Data Manager, you want to change the future. You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
What will you be doing?
The Site Management Associate performs investigative site recruitment/feasibility, essential document collection and review, clinical status
tracking, in-house site management, and data review activities in accordance with the study protocol, client and/or PRA standard operating
procedures (SOPs), and all applicable guidelines and regulatory requirements (e.g. ICH-GCP, and country/region specific).
Recruits and evaluates potential sites for participation in late phase studies
o Utilizes assessment tools, questionnaires, and study site materials in evaluation of study sites
Performs Essential Document Collection, Review, Maintenance and Close Out activities
o Ensures sponsor and investigator obligations are met in compliance with applicable guidelines and local
o Supports investigators with submissions according to applicable local, regulatory, and IRB/IEC
Performs Study Tracking to ensure that the study files are current, accurate, and complete
o Tracks clinical study management information in CTMS
o Documents site and client contact and study interactions in a timely and professional manner
Liaises with Internal and External Customers to meet project specific goals
o Participates in sponsor and project-related meetings and appropriately interacts with client and team
o Acts as a liaison with clinical supply/service vendors and other functional area team members to meet
project team goals
Manages study sites to ensure adherence to the late phase study design
o Acts as primary point of contact for assigned study sites
o Tracks patient enrollment, study supplies, and data entry efforts for assigned study sites
o Escalates unresolved issues to the appropriate project team member(s)
o Will have study coordinating center responsibility on a rotational basis as assigned by Manager, or
Performs data review and query resolution tasks for assigned sites
o Reviews the clinical data for enrolled patients and data discrepancies within clinical databases
o Creates queries related to the CRF/eCRF data (DCF - Data Clarification Forms)
o Communicates with study sites to achieve resolution to outstanding data queries
Follows database closure procedures for freezing, locking, and unlocking clinical databases
Resolves internal and external clinical issues for client research projects
o Assists in maintaining clinical project documents, including Site and/or Data Management Plans,
Monitoring Guidelines, Data Review Guidelines, Site Operations Manuals and Monitoring Visit Letter
Templates under guidance of Operational Study Manager/Lead SMA
o Interacts with client(s), vendors and PRA functional areas as secondary project contact for clinical issues
o Provides clinical status information to team members and project management under guidance of
Operational Study Manager/Lead SMA
Implements and monitors post-marketing studies to ensure sponsor and investigator obligations are being met
and are compliant with applicable local regulatory requirements and ICH guidelines
Coordinates and conducts telephone PSSV, SIV, and COV visits in order to assess the qualification of potential
study sites, to initiate and instruct site personnel on the proper conduct of studies, to review data and ensure
accuracy of data collected, and to terminate studies
o Provides regular clinical status information to team members and project management
o Ensures Serious Adverse Event (SAE) reporting according to project specifications
What do you need to have?