Clinical Trial Manager/Project Manager (US-East-Coast Remote)

Responsibilities

The Clinical Trial Manager (CTM) is accountable for achieving successful delivery of clinical activities at the project level by meeting internal and external contractually agreed client and regulatory requirements according to time, quality/scope and budget constraints. The Clinical Trial Manager (CTM) leads and directs cross functional teams and understands/manages client expectations. In addition, the Clinical Trial Manager (CTM) proactively identifies, resolves/mitigates and escalates risks and/or issues. Depending on the business unit the descripted accountabilities may or
may not apply.

Daily Management of a Trials
• POC for sponsor, sites and CRAs
• Study Tracking and Monitoring trip report review

Provides Project Oversight and Leadership for Clinical Deliverables:

Leads and manages the start-up and clinical teams

Plans and leads execution of the day to day activities for the monitoring of a clinical study

and communicates consistently with the clinical team providing project objectives, expectations and

status updates. Works with the team to set priorities

Takes the initiative to make things happen and leads and supports the relevant staff ( this may

include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead

(GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to

ensure the successful activation of trial sites according to time, quality/scope and budget

parameters

Motivates the clinical team

Ensures effective communication plans are place for the clinical team Ensures effective escalation

plans are in place for the clinical team

Works with the Project Manager (PM) to facilitate cross functional team and sponsor communication

for proactive, study-wide problem solving regarding study progress and trial issues during the

study

Monitors the quality of clinical deliverables and addresses quality issues with the appropriate

team member

Oversees the GRAL, LRAL and IHCRA to ensure that all non-safety periodic updates, progress reports and

renewals and/or end of study notifications are performed in accordance with the trial protocol, local regulations,

ICH-GCP and any other processes or procedures governing the clinical trial.

Identifies metrics and trends across team members, countries, regions and uses the information to

promote improvement in quality and consistency of execution.

Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans,

responds completely and accurately to audit reports, provides team with project-specific audit process to ensure

adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and

then Sponsor Organizes project specific compliance plans for key processes, tools and systems

Reviews filing of Essential Documents in the electronic Trial Master File to ensure sponsor and investigator

obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines

Project Finance

Provides Time Entry Guidelines to the relevant study team members in adherence with project scope and budget;

monitor burn rates, escalating issues with potential solutions to the Project Manager (PM).

Forecasts units and hours and generic resources for the start-up and monitoring activities, determines worked units

and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget

Ensures that forecasted units are achieved as planned and within the budgeted FTE

Identifies out-of-scope tasks from clinical team and escalates as required

Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval

by the relevant PRA staff.

Customer Relations (Internal & External)

Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are

achieved

Serves as primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional

areas, escalating as required

Participates in client meetings, assisting with presentations as required

Contributes to Business Development activities

Qualifications

Education:

• Bachelors Degree in health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.

Experince requried:

• 2+ years of clinical research project management experience required