Site Activation Manager

This is a fully remote position, open to applicants in Portugal, +1 more state.

📋 Description

• Act as the main point of contact and accountability for study initiation and maintenance activities on designated projects.

• Supervise the activities of functional groups involved in site activation to ensure that critical path tasks are completed punctually and within budget constraints.

• Gather, manage, monitor, and analyze site activation activities.

• Assist with feasibility studies and site identification efforts as necessary.

• Accelerate the Site Qualification and Selection process.

• Relay Site Activation and Regulatory project updates to the Sponsor, GPL/CPM, and project team members.

• Create risk assessments and mitigation strategies for project deliverables.

• Ensure that relevant study activities are reflected in work order budgets.

• Monitor out-of-scope activities using Change Notification Forms and ensure completion through change-order execution.

• Develop and uphold site activation project plans.

• Contribute to the creation of SOPs, best-practice guidelines, training materials, and coaching initiatives.

• Provide insights for departmental process enhancement initiatives.

• Establish and interpret site activation metrics to drive corrective actions for deliverables, milestones, and KPIs.

• Engage in business development activities, proposals, and bid defense meetings.

• Report or escalate issues to Site Activation leadership to mitigate delivery risks.

• Adhere to SOPs, ICH GCP, and relevant national regulations.

• Collaborate with functional contributors and vendors.

• Perform additional assigned tasks.

⛳️ Requirements

• Bachelor’s degree in medical, biological, physical, health, pharmacy, or a related scientific field, OR an associate degree or equivalent education/training coupled with clinical research experience.

• At least 4 years of experience in the CRO/pharmaceutical industry, preferably in start-up management, project management, and/or site management.

• Skilled in cross-cultural communication.

• Proficient in both spoken and written English.

• Knowledge of regulatory processes and guidelines.

• Understanding of clinical project initiation, planning, execution, and overall project management.

• Familiarity with ICH GCP Guidelines and FDA/EU Clinical Trials Directives/National regulations.

• Capability to handle multiple tasks in a dynamic and fast-paced environment.

• Strong leadership and organizational management abilities.

• Good judgment and independent decision-making skills.

• Proven problem-solving capabilities.

• Ability to inspire, lead, and engage a team effectively.

• Excellent interpersonal, verbal, and written communication skills.

• Demonstrated ability to collaborate across various business units.

• Organized, methodical, and self-driven work approach.

• Proficient in Microsoft Word, Excel, PowerPoint, and digital systems.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and harmonious teams.

• Accessible leadership.

• Equal employment opportunities.

• Exceptional employee experiences.