CTMS Business Support Analyst
- Experience Level
- Experienced (non-manager)
Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 13,000+ employees strong, operating in more than 80 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.
Who are you?
You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for clinical development. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What will you be doing?
The focus of this position is to support operational aspects of Global Clinical Operations (GCO) managed clinical trials. Scope of work will include tasks associated with trial start-up, execution or close out, in all phases of clinical trial development. The range of tasks will include activities assigned by the CTMS management team and may vary to some degree depending on the therapeutic area and trial-specific requirements. Additional tasks may be assigned to enhance development.
- Assist with activities as assigned by the CTMS Management team which support trial management activities across the various phases of a trial (start-up, execution and close-out).
- Member of the Study Management Team (SMT) for each study assigned. Responsible for setting up meetings and maintaining minutes.
- Assist Study teams with CTMS Study Build activities and coordination. Attend study onboarding meetings and collect study related information. Liason between CTMS Business support team and Study team members, transitions agents, etc.
- Manage CTMS with expectations that study status is available at all times; work with local Affiliates to ensure trial specific data are up-to-date, complete, accurate and consistent.
- Manage eTMF (Central Administrative File) across various phases of a trial
- Support team-specific Sharepoint sites to ensure availability of all central trial documents
- Ensures investigator/IRB lists are available for Clinical Study Reports
- Liaise with Contract Research Organization/Academic Research Organization teams if outsourced trial and as defined by GTM
- GCO staff: CTMS Business Management team and business support team members. Therapeutic-specific Clinical Operation Head, team CPL and GTMs, GTM-CTAs, LTMs, IDAs, and SMs within Therapeutic Area (business unit) and colleagues from other therapeutic areas
- Contacts Inside the Company: Global Pharmaceutical Sourcing Manager, Accounts Payable, Integrated Data Services, Clinical Teams, Finance
- Contacts Outside the Company: vendor and CRO/ARO contacts as appropriate
- Supervision: This position reports to Clinical Program Leader
What do you need to have?
Education and Experience Requirements/Qualifications:
- Associate’s degree (or equivalent) required and 1-2 years relevant work experience. Bachelor’s degree preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Good organization skills, good written and verbal communication skills
- Excellent independent time management skills; Proven ability to plan and track deliverables and timelines; Individual must work well in a dynamic environment and be able to prioritize and respond to changing needs of the business
- Proficient Microsoft Office applications and use of Internet, EXCEL, POWERPOINT, WORD
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.