Senior Site Activation Manager

Worldwide Clinical Trials; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Senior Site Activation Manager to lead site start-up activities within the assigned therapeutic area. The role coordinates and oversees identification of sites, contract status, regulatory documents, and EC interactions for NA countries, ensuring site activation complies with GCPs and regulations.

You will mentor teams, manage timelines and budgets, and contribute input to proposals or budgets when needed.

Qualifications

• A minimum four-year college curriculum or equivalent with a major concentration in medical, biological, physical, health, pharmacy or other related science.
• Seven years relevant CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management.
• Proficient in cross-cultural communication and in English (spoken and written).

Responsibilities

• Serve as the primary point of communication and accountability for study start-up activities on assigned projects.
• Oversee project activities of functional groups involved in site activation to ensure critical path activities are completed on time and within budget.
• Ensure accurate compilation, management, tracking and analysis of site activation activities in a timely manner.
• May support feasibility and/or site identification activities, as needed.
• Work closely with assigned team members to expedite the Site Qualification and Selection process.
• Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team.

Skills

Leadership

Project management

Strategic planning

Scheduling

Cross-cultural communication

English proficiency

Education

Bachelor's degree in medical/biological/physical health science

Two-year college + 4 years clinical research

Job description

What the Senior Site Activation Manager does at Worldwide

This is a seasoned leadership role 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. Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area.

What you will do

• Serve as the primary point of communication and accountability for study start-up and maintenance (if applicable) activities on assigned projects
• Oversee project activities of functional groups involved in site activation to ensure critical path activities are completed on time and within budget
• Ensure accurate compilation, management, tracking and analysis of site activation activities in a timely manner
• May support feasibility and/or site identification activities, as needed
• Work closely with assigned team members to expedite the Site Qualification and Selection process
• Effectively communicate Site Activation & Regulatory (if applicable) project status to the Sponsor, GPL/CPM and project team

What you will bring to the role

• Proven leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
• Demonstrated ability to exercise sound judgment and consistently make decisions independently to proactively prevent and solve problems
• Demonstrated ability to consistently and positively have an impact on initiatives relating to interacting with sites and/or customers
• Demonstrated ability to motivate, lead and engage a team to consistently and successfully achieve meaningful goals
• Demonstrated ability to perform and thrive in ambiguous situations
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment

Your experience

• A minimum four-year college curriculum or equivalent with a major concentration in medical, biological, physical, health, pharmacy or other related science, or two-year college degree plus four years experience within clinical research
• Seven years relevant CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience
• Proficient in cross-cultural communication
• Proficient in both spoken and written English