PRAHS Senior Study Manager-Oncology - Home Based in United States
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Who are we?
We Are PRA.
We are 17,000+ employees strong, operating in more than 90 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 life saving drugs into the hands of 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.
The Study Manager will be accountable for the operational planning, feasibility, and execution of a clinical protocol.
What will you be doing?
Sr. Study Manager 1
May lead or support a study or studies, depending on size/complexity.
As lead, will be responsible for the following:
Operational point of contact for trial execution and all trial deliverables
Manages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planning
Manages deployment and interactions with external vendors (e.g., IVRS, PRO)
Initiates planning for Investigator meeting and protocol training.
Plans and assesses protocol ancillary supplies
Completes trial set-up and maintains SPECTRUM
Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT
Initiates recruitment/retention planning & enrollment tracking
Responsible for tracking study related details (e.g., specimens, queries)
Oversees protocol training activities including IMs and CRAs training meetings
Ensures appropriate postings to investigative site portals
Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)
Point of escalation for study related operational issues
Responsible for operational details at Operational Reviews
Responsible for creating and maintaining project schedule and collaborating with Program Lead
Sets up and maintains Trial Master File (eTMF)
Ensures alignment of budget with protocol needs
Responsible for executing protocol within the budget
Responsible for creating and maintaining ADI logs
Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group
Develops study related manuals (e.g., administrative binder, lab manuals)
Manages Emergency Unblinding (EUB) Call Center activities
Co-authors newsletters with CS
Approves contracts, invoice payments and change orders for vendors, as necessary
Responsible for end of study reconciliation (clinical & ancillary supplies)
Oversees all HQ close-out tasks
Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking
Supports CS activities as needed to achieve CTT deliverables
Interface with External Data Coordination and Data Management
Responsible for quality control and inspection readiness at all times
Responsible for risk assessment, mitigation planning and execution
What you need to have:
Senior Study Manager 1
- BS/BA/MS/PhD with 7+ yrs clinical research experience
Minimum Years of Experience
Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required.
Proven ability to meet aggressive timelines
MS Project experience preferred
Excellent Excel and PP skills required
TA- Oncology experience required
Global experience required
Excellent oral (including presentation) and written communication, computer/database management, and project management skills required
Home Based position in US or Canada
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/