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Excellent Job Opportunity for the position of Clinical Trial Feasibility Manager (6010313)
Ref No.: 17-01729
Location: East Hanover, New Jersey
Position Type:Contract
Start Date / End Date: 01/24/2017 to 07/24/2017
Job Title: Clinical Trial Feasibility Manager
Work Location: East Hanover, NJ
Length of Assignment: 6 Months
Client: A Big Pharmaceutical Company


Job Description:
The TOM will be accountable for the oversight and coordination of the global monitoring operational aspects of clinical trials execution, from start-up to close-out, in collaboration with regions and CPOs, in compliance with Client processes, GCP/ICH and regulatory requirements. This includes strategic and operational planning, feasibility assessment, trial allocation, startup activities coordination, patient recruitment, clinical data collection and delivery of timely, high quality submission data.

Major Accountabilities:
Partner and agree with GPT/ICT/CTT on realistic and stretched project timelines, on behalf of the GMO organization. Communicate planned milestones to GMO stakeholders and update CTTs on operational activities at the Region/CPO level throughout the conduct of trials to ensure efficient and effective delivery of GPT Objectives.
Drive conduct of medical and operational feasibilities, and communicate aggregated feedback to clinical teams; ensure closure of the loop on feedback given during feasibility process.
Lead study allocation process for assigned trials within agreed timelines to ensure optimal patient accessibility and alignment with regional strategies and country needs.
Author of the monitoring plan.
Develop planning for prospective management of operational risk for each phase of a clinical trial.
Review, approve and ensure updates to CCGs as appropriate during trial conduct. Perform User Acceptance Testing for EDC system, track and facilitate 3rd party vendor account set-up (incl. Labs, imaging vendors, etc.).
Drive study startup by coordinating preparation of FPP by respective CTT LF members, acceptance by CPOs and tracking progress of SSU milestones in alignment with regions and CPOs.

Additional Responsibilities:
Ensure patient recruitment as per plan, including contingency planning and communication of timelines for major milestone deliverables, in coordination with regions and CPOs.
Responsible for data quality of the assigned trials. Work with Country Heads and RQMs as needed to raise awareness to trends that may indicate issues with quality.
Ensure clinical data flow as per plan, including contingency planning and communication of timelines for major database lock milestone deliverables, in coordination with regions and CPOs. Work closely with Data Management and Clinical Teams to address any data flow or trial quality issues and recommend solutions.
Facilitate development of trial level operational training materials within CTT with relevant line functions.
Actively participate to the development of reporting methodologies, and implement performance reporting for trial monitoring. Provide ongoing information and regular updates to management (e.g. to PMB) and through the GMO organization, including remediation actions.

Required Skills:
At least 6 years experience in clinical research, in planning/executing and/or monitoring clinical trials.
Thorough knowledge of Good Clinical Practice and clinical development process
Solid understanding of clinical trial design, trial execution, project management and operations.
Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision.
Understand and apply medical and business knowledge to clinical trial execution
Project/trial management and/or CRA or CRA management experience preferred
Excellent negotiation and conflict resolution skills
Demonstrated ability to collaborate across partner functions in a matrix environment
Demonstrated ability to influence without direct authority
Strong interpersonal skills
Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision.
Ability to distill a large volume and frequently changing scientific and clinical information, inorder to understand and apply to medical and business objectives in clinical trial execution
Project/trial management and/or CRA or CRA management experience preferred with demonstrated strategic planning, critical thinking and problem solving skills
Demonstrated ability to collaborate across partner functions in a matrix environment
Strong interpersonal skills including negogiation and influencing for results
High level verbal and written communication skills

Education:
Advanced degree or significant relevant experience in life science/healthcare required.

Interested candidates can share their most updated resume at wajid.khan@artechinfo.com or they can reach out to me on #973-967-3412 Ext:3412