Site Mgmt Associate - Real World Solutions

PRA Health Sciences Blue Bell , PA 19422

Posted 4 weeks ago

Real World Solutions

  • Site Management Associate


  • Blue Bell, PA - this is NOT a Work From Home Opportunity

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 17,000+ 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 help get life-saving drugs into the hands of those who need them most.

Who are you?

You are someone who wants to be part of a fabulous group; a group that really supports their folks and promotes from within! Science, Clinical Trials and Data are your passion, and you want to be a part of drug research and development, then this is for you! You also enjoy tracking clinical studies and being a part of the big picture!

Still here? Good. Because if this is you, Real World Solutions would love to meet you!

What will you be doing? As a Site Management Associate, you will perform 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).What do you need to have?

  • Read, write, and speak fluent English; fluent in host country language required.

  • Experience with the document collection process

  • Prior experience using computerized information systems required.

  • Extremely organized, strong time management skills and don't mind being on the phone 90% of the time

  • Minimum of one year Clinical trials support, Data Coordination or pharmaceutical industry experience required.

  • Office-based or clinical trial experience required

  • A Bachelor's of Science Degree in a clinical, science, or health-related field is required.

  • Familiar with ICH and GCP guidelines

  • Familiar with clinical trial process a plus

  • Prior experience using computerized information systems required; experience with Electronic Data Capture, PC Windows, word processing, and electronic spreadsheets preferred


  • Experience communicating with Sponsors, vendors, CROs, IRBs, and/or sites

  • Experience with Electronica Data Capture (EDC systems)

  • Prior customer service experience preferred

  • Proficiency in additional languages preferred

  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred.

  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Operational Study Manager Real World Solutions (US Or Canada Remote)

PRA Health Sciences

Posted 4 weeks ago

VIEW JOBS 3/7/2020 12:00:00 AM 2020-06-05T00:00 Operational Study Manager - Real World Solutions Location - Blue Bell, PA; Raleigh, NC or Remote US or Canada Achieves successful delivery of operational activities (site management, clinical monitoring, and/or data review) by meeting internal and external client requirements. Oversees the management of physician sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines (such as ISPE GPP) and applicable regulations, as well as SOPs. Contributes to Business Development Activities by participating in proposals and bid defenses as required. Along with the OSM (Operational Study Manager) role on a project, may function in a PM role with mentoring and supervision. Key Responsibilities: * Manages all study site related activities in a project including * Project Planning, Set Up and Conduct, Communication and Reporting, Training and Oversight * Plans for all activities in a project related to investigational sites and generates the related planning documents depending on the scope of work (including but not limited to Study Start-up Plan and Site Management Plan). * Serves as primary liaison for the client for all clinical operations issues, including but not limited to site management and applicable clinical monitoring issues, escalating as required. * Defines and provides project-specific training for the site management and regional monitoring team and ensures relevant training is completed before the team members start on a specified task. * Leads the site management and regional monitoring team on a project, providing oversight and mentoring as required. * Supervises patient enrollment/registration, study data review, and query resolution efforts. * Reviews and approves monitoring visit reports and ensures tracking and resolution of ongoing site issues. * Manages the operational budget and identifies out of scope tasks from the operational team and escalates as required. * Collaborates with Clinical Informatics in achieving successful delivery of data management deliverables, meeting internal and external client needs: provides day-to-day oversight of the clinical data review process during study conduct * Reviews and provides input on data management plans for content and structure * Contributes to Business Development activities, participating in proposals and bid defenses as needed. * Contributes to Business Development activities, participating in proposals and bid defenses as needed. Qualifications: * Ability to understand the big picture - the scientific goal of their project, how the study design relates to that, why the client is doing the research, what the regulatory requirements will be for a particular study (in late phase, this does vary more than in PR), independent problem solving to make sure timelines are met, assessing risk at the project and also site level, prioritization to meet client needs and deliverables. The OSM needs to also understand how the smaller site-level tasks that the SMAs are doing fit into this big picture. * The OSM role is client-facing so we need someone with solid experience who will be able to handle demanding clients. We need the clients to feel like they have confidence that they're in good and experienced hands, someone who has experience in a variety of therapeutic areas/study designs in late phase is ideal. * Strong leadership skills as they lead the SMA team - approachable enough to encourage them to escalate issues and be a mentor but, again, strong enough to keep them on track and accountable. * Good, polished presentation skills (delivering a presentation is part of the interview) - they will need to participate in bid defense meetings and regularly present progress updates in client meetings and they can't get rattled by tough questions. * Data management experience is also an important asset for OSMs to have. This is an important element of the role and really, what our clients are looking for in the end is clean data of high quality. * 3+ years clinical research experience including site monitoring and management of study sites from start-up through close-out * Experience leading professional staff in a clinical research environment * Proven skills with electronic data capture software * Read, write and speak fluent English * Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. PRA Health Sciences Blue Bell PA

Site Mgmt Associate - Real World Solutions

PRA Health Sciences