QuintilesIMS Clinical Project Manager (Dermatology -Office/Home based) - Novella Clinical in Atlanta, Georgia

Description:

Candidates can be Home-based anywhere in the USA for this opportunity.

The primary role of the CPM position is to administer, maintain, and coordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs) and Process Documents (PDs) and the Study Responsibilities Task List. The CPM position independently manages multi-center clinical trials, moderate to high complexity or global programs. This position may function as the Global Project Manager by coordinating regional CROs and partner activities within a project. The CPM has full responsibility for facilitating and managing the cross-functional team, interacting with sponsors/vendors and managing clinical trial timelines, project budget and deliverables. The CPM may travel up to 40% to investigative sites, investigator meetings or for other business related reasons

ESSENTIAL DUTIES ANDRESPONSIBILITES

  • Successfully manage the relationship with the sponsorincluding establishing expectations with deliverables.

  • Ensures roles and responsibilities are clear across internaland external organizations to achieve desired results.

  • Ensure that projects are delivered on-time, withinscope and within budget

  • Communicates with the internal project team andsponsor/vendor project team. Conducts and coordinates team meetings (approvesagenda and reviews minutes).

  • Manage changes to the project scope, project schedule,and project costs including budget management, resource allocation,informing management and client for out of scope activities.

  • Participates in internal project governanceinitiatives

  • Develop a detailed project plan to monitor and trackprogress

  • Measures and reports project performance utilizing keymanagement tools (Risk Management Plan, Project Plan, project reports).Performs risk management to mitigate risks and provide clear direction toteam.

  • Reports and escalates issues to management as needed

  • Plans, develops, and presents meeting presentations andmaterials for Kick-off Meeting, Investigator Meeting, and Face to FaceMeetings.

  • Oversees site feasibility and selection process andconsults with the sponsor on the final site list.

  • Forecast investigational product needs; oversee supplychain.

  • Collaborates and works closely with Lead CRA and/or CRAManager.

  • Participates in Bid Defense and Capabilities Meetings asrequired.

  • Directs and manages project staff including, training,mentoring, and performance management.

  • Mentors, trains project team members such as PA, CTA I&II, CTM I & II on their roles and responsibilities.

  • Leads or supports Dermatology programs to improveproject management processes and tools.

  • Miscellaneous duties, as necessary, in support ofClinical Monitoring and Project Management initiatives, and Dermatologybusiness priorities and objectives.

  • Clinical Trial Managers

  • Clinical Trial Associates

  • Project Assistants

  • Direct Report to Project Director regarding jobperformance and evaluations.

SUPERVISORYRESPONSIBILITIES

REPORTING RELATIONSHIP

Qualifications:

EDUCATION (AND/OR EXPERIENCE)

  • College degree in any of the life sciences preferred, or with a certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) with related work experience.

  • ≥ 5 years experience in a project team position or working within the health sciences field in a similar positions.

  • Advanced knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority.

  • Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint, MS Project.

  • Effective financial management skills.

  • Strong written and verbal communication skills.

  • Effective time management and organizational skills.

  • High level of facilitation skills to work with different types of team members

  • Excellent mentoring and supervisory skills in order to build a staff that works as a team delivering uniform product to each sponsor

  • Expertise in delivering presentations

  • Attention to detail and accuracy in work

  • Strong customer service orientation.

  • Ability for travel (e.g., Investigators Meetings, KOM, FTF

EEO Minorities/Females/Protected Veterans/Disabled

Or

QUALIFICATIONS

Primary Location:

USA-North Carolina-Research Triangle Park

Other Location(s):

USA-Missouri-Saint Louis, USA-North Carolina-Greensboro, USA-New Jersey-Parsippany, USA-Indiana-Indianapolis, USA-Kansas-Overland Park, USA-Pennsylvania-Philadelphia, USA-New Jersey-Hackensack, USA-California-San Diego, USA-Minnesota-Minneapolis, USA-Georgia-Atlanta, USA-California-Oakland, USA-California-Sacramento, USA-New Jersey-Berkeley Heights, USA-North Carolina-Durham, USA-Louisiana-New Orleans, USA-Ohio-Cincinnati, USA-North Carolina-Wilmington, USA-Illinois-Chicago