Project Specialist

What you’ll be doing:

• Partners with the Project Manager (PM) to ensure overall Project Delivery through coordination and oversight of the cross-functional project team

• 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.

• 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

• 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

What we are searching for: 

• Associate’s 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 a 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 preferred

• 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