Senior Study Manager - ID/Vaccines - Home Based at Pharmaceutical Research Associates, Inc.

Posted in Executive 13 days ago.

Location: Raleigh, North Carolina

Job Description:

Pharmaceutical Research Associates, Inc.

Senior Study Manager - ID/Vaccines - Home Based


Job ID: 2021-84574
Type: US
# of Openings: 1
Category: Clinical Trial Management



ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.


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- vaccines/ID preferrred but not 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

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.


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