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PRAHS Senior Study Manager-Oncology - Home Based in United States

We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.

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

Educational Requirements

  • 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.

ID: 2020-70541

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL: http://prahs.com/

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