We are currently searching for a skilled professional to join a well-known client’s team as a Remote Clinical Trial Manager. The Clinical Trial Manager is responsible for overseen performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Assist and may provide oversight for all phases of clinical trial activities (feasibility, start-up,

maintenance and close-out)

• Assist and may lead in development of internal and study related documents, as applicable

(i.e. Informed Consent Forms, study reference manuals, newsletters, etc.)

• May lead smaller Phase Ia, Ib, or II clinical trials or play a supporting role in more complex

phase I, II or III clinical studies with mentorship and oversight until competence for tasks is

established.

• Supports the development of Clinical systems (e.g. EDC, CTMS, eTMF, IRT, etc.). Integral

user of these systems.

• Oversight of study team and site training

• Facilitation and oversight of quality processes for assigned project(s) including working with

cross functional team members (e.g. Regulatory, Quality Assurance, etc.)

• Primary reviewer or provides oversight for study regulatory documents

• Supports and may lead, if delegated, the development and implementation of program and

study required plans and budgets for assigned projects and delivers the plans as directed

• Supports the development and implementation of robust contingency, communication, and

monitoring plans

• Provides field-based monitoring and site management support, as required

• Support integrity of final study files and documentation, including eTMF, final TLFs, and final

study data archival

• Ensures internal systems reflect latest study status

• Interacts with clinical researchers and sites as directed

• Management of study drug distribution and accountability processes and documentation

• Participate in or may lead (if the Clinical operations Lead or assigned by the Clinical

operations Lead/Study Manager) Study Team and Contract Research Organization (CRO) /

Vendor meetings, as needed

• Solicit meeting agenda topics, support agenda development, and distribute meeting

agendas, as appropriate

• Review meeting minutes and approve for accuracy of information

• Provide oversight for study regulatory documents, and review as required

• May mentor and support study or department training activities for Clinical Operations staff

• Support or may lead initiatives for the Clinical Operations and overarching Development

organization on functional and cross functional projects

• Organizes, prepares reports, prioritizes and summarizes data, materials, and information for

projects, per schedule and ad hoc requests

• Creates, maintains, updates and reconciles spreadsheets and study trackers to support

various projects such as: (but not limited to): financial trackers, review and finalization of

study team minutes, trial master file (TMF) tracking, etc.

• Solicits cross functional input to create, maintain, update and/or reconcile project and

timeline tracking software or spreadsheets and various summary reports to inform various

project team stakeholders

• Create content for presentations and materials for functional project meetings

• Identification of potential deliverable or timeline challenges or bottlenecks; presents

suggested prioritization or options

• Effectively communicate with study team members and work closely with Clinical Operations

Lead/Study Manager

• May serve as primary contact for specific vendor needs

• Participates in process improvement and quality-related initiatives associated with study

execution and deliverables.

• Monitor, interpret, and act on study and vendor metrics

• Support the design, preparation, planning, and implementation of upcoming clinical studies

• May contribute to departmental SOPs, policies, and guidelines in a cross-program manner

REQUIRED EDUCATION AND EXPERIENCE

• BA/BS degree preferred with 6 years of professional experience working in a clinical

research environment (clinical site, CRO or biotech/pharma company) or demonstration of

equivalent capability in a Clinical Operations role

• Strong knowledge of FDA regulations, ICH guidelines and Good Clinical Practice (GCP)

• High level of energy, passion for job, creative problem solver, proactive and highly productive

• Willingness to collect and summarize data and information from a variety of resources and

stakeholder team members / departments

• Must have strong computer skills working with Microsoft office programs (Word, Excel,

PowerPoint, Outlook and Microsoft Project)

• Outstanding organizational skills

• Team player with excellent attitude and excitement to cultivate strong cross functional

relationships

• Excellent written and oral communication skills (timely, clear)

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment andRetention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.