Study Manager – Remote 

Location
Raleigh, North Carolina (US)
Salary
Competitive salary and benefits
Posted
Aug 29, 2018
Closes
Sep 18, 2018
Education
BS, PHD
Hours
Full Time

Study Manager – Remote  
Job # 2018-48401

 Accountable for the operational planning, feasibility, and execution of a clinical protocol. May lead team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning, communication plans, preparation of status update reports, study closeout activities). May serve as the clinical trial team (CTT) lead. Leads team for timeline management, risk identification and mitigation, issue resolution. May facilitate and collaborate with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc) in support of clinical study objectives. Accountable for managing any study specific partners and/or vendors.

• Degree in the Life Sciences or significant experience in clinical development (> 11 years)
• Bachelor’s degree with 7+ years; or MS with 5+ years; or PhD with <2 years relevant career experience
• Pharmaceutical and/or clinical drug development experience.
• Excellent oral (including presentation) and written communication, computer/ database management and project management skills.

Study Manager Job Role Overview:

Responsible for the operational execution and conduct of clinical trials (both internally and externally sourced). Leads Clinical Trial Team.  Collaborates with the Clinical Director and Clinical Scientist and Program Lead for the scientific and strategic aspects of the protocol and with regional representatives for country operational input. Responsible for managing project schedule.

Study Manager Key Tasks:

•              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 CPAC

•              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 risk assessment, mitigation planning and execution

•              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

•              EDC and DM interface is core function of SM

•              Responsible for quality control and inspection readiness at all times

Please send CVs to lamelzarose@prahs.com