Project Specialist (12 month Contract)

Premier Research•Regional_NC, NC

23h

About The Position

Premier Research is looking for a Project Specialist to join our Business Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

Requirements

Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience OR Bachelor’s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management
Basic knowledge of ICH/GCP regulations
Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
Basic knowledge of project management terminology and guidelines
Strong computer skills in MS office suite required

Responsibilities

Partners with the Project Manager (PM) to ensure overall Project Delivery through coordination and oversight of the cross-functional project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety).
Collects information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases
Identifies risks associated with milestones and deliverables. Documentation of risks are logged and resolved with cross-functional teams.
Write and disseminate SOP’s and project documents, including procedures, proposals, progress reports and presentations
Responsible for facilitating team communications and maintaining documentation internally and externally.
Maintains internal and external project team contact lists.
Ensures effective communication by scheduling internal and external team meetings, developing agendas, capturing minutes, and managing the action/decision log.
Creates and distributes study newsletters as required.
Applies study knowledge to maintain, update, and disseminate study timelines in accordance with the study proposal, as well as feedback from functional groups and the sponsor.
Manage and track budgets related to vendor projects including tracking of supplies and invoices.
Track out of scope services and assists in preparing Change Orders.
Tracks supplies, invoices, and budgets relating to vendor management, as appropriate.
Ensures projects are audit ready, i.e., project tasks are completed in accordance with project plans (customizes project templates when applicable) and SOPs and are filed to TMF, as appropriate.
Initiates TMF development (TMF filing plans, tracking/qc tools, and TMF access); ensure functional group compliance and that the TMF is accurate, complete, and audit ready as all times.
Helps to identify and track applicable SOP updates and SOP Deviations at the study level.
Creates and manages the required project systems, SOP indices, and study team lists, as applicable.
Manages study team/contact lists, system access requests, and e-mail distribution lists as required.
Collaborates with the functional leads in the development of team trainings or meeting presentations and maintains the study training matrix.
Ensures completion and proper documentation of study specific training requirements as directed by the PM.
Assigned additional project / ad hoc activities to manage independently.
Develops and provides training and support to other team members, as appropriate.
Leads department improvement activities.
Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures
Participates in corporate initiatives and actions that ensure the continued success of the company.
Ensures accurate and up to date personal training record.