Site Activation Project Manager at worldwide

Description

Accountable for site activation project management and delivery activities within the assigned therapeutic area. Responsibilities include coordination, collaboration and oversight of site identification and central and local ECs (for NA countries only) activities, progression of essential documents collection, monitoring of investigator and site contracts status, and any other country and/or study specific site activation tasks necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). May also include pre award support by providing site activation related input into the proposal text and budget items.

Required Skills

Leadership
Organizational Management
Planning
Strategizing
Managing
Monitoring
Scheduling
Critiquing
Sound Judgment
Decision Making
Problem Solving
Interpersonal Skills
Communication Skills
Collaboration
Team-Oriented Work Style
Regulatory Processes and Guidelines
Initiation, Planning, and Execution of Clinical Projects
ICH GCP Guidelines
FDA/EU Clinical Trials Directives/National Regulations

Additional Information

Required Previous Experiences: 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management.
Preferred Qualifications: Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing.
Ability to exercise sound judgment and make decisions independently and to proactively identify and solve problems.
Ability to provide experience and input into initiatives relating to interacting with sites and/or customers.
Ability to motivate, lead and engage a team.
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.
Strong oral and written communication skills to clearly and concisely present information.
Demonstrated ability to collaborate across the business.
Team-oriented work style; seeks and gives guidance.
Understanding of regulatory processes and guidelines.
Understanding of initiation, planning, and execution of clinical projects and overall project planning.
Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications).
Ability to handle multiple tasks in a fast-paced and constantly changing environment.
Ability to work in an organized, methodical, and self-motivated manner.
Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude.

About worldwide

worldwide

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Site Activation Project Manager at worldwide

Description

Required Skills

Additional Information

About worldwide

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Required Skills

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