Senior Project Manager

Overview

As a Senior Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

 

We are currently looking for an experienced Global Clinical Project Manager to join our client, employed by ICON. This is a home-based role.  The ideal canddiate will have 8 years of CTM/PM experience on a global level along with Immunology experience. 

Responsibilities

What you will be doing:

 

• Lead the Study Management Team including providing updates to all trial team members on deliverable status.
• Ensure availability of required reports to support real time tracking of trial status according to trial plan.
• Manage timely and accurate documentation and communication of trial progress.
• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
• Act as primary contact for Country and Regional staff.
• Act as the primary contact person for the local teams within GD.
• Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
• Ensure issue escalation and drive issue resolution.
• Work closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
• Contribute to data collection to support the site selection process.
• Autonomy in execution of clinical trial management services.
• Depth of knowledge with clinical trial management services.
• Provide coaching/mentoring to less experienced TDMs, if applicable.
• Assumes additional responsibilities or special initiatives such as Champion or Therapeutic Area Expert, as applicable.
• Given assignments that are more complex and/or have a greater potential impact on business results.
• Lead a team of TDMs across a project/program, on insourced and outsourced studies.

Qualifications

You are:

 

• BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• 8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
• Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
• Effective leadership skills and ability to manage multiple stakeholders.
• Proven ability to lead a team through formation stages, up to operating as a high performing team.
• Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
• Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
• Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
• Strong project planning/management.
• Independent complex decision making.
• Solution oriented and proactive risk identification and mitigation.
• Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems.
• Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.
• Travel.
• Proficient in speaking and writing local country language and English.
• Effective verbal and written communication skills leading to successful team collaboration
• Strong decision making. Solution oriented.
• Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
• Experience in developing presentations and presenting key information to stakeholders.
• Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.
• Ability to proactively and autonomously identify and preempt budget issues and work with key stakeholders to resolve.

Please note we cannot consider the following countries for this role: Netherlands, Belgium, Germany, South Africa, Turkey, Israel, Romania, Bulgaria, Hungary or Czech. 

What ICON can offer you:Our success depends