Site Activation Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the main point of contact and accountability for the initiation and ongoing activities of assigned studies.

• Supervise the functional teams involved in site activation to ensure that essential activities on the critical path are completed punctually and within budget.

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

• Assist with feasibility assessments and site identification as required.

• Accelerate the Site Qualification and Selection process.

• Relay the status of Site Activation & Regulatory projects to the Sponsor, GPL/CPM, and project team.

• Develop risk assessments and mitigation strategies for project deliverables.

• Ensure that pertinent study activities are incorporated into the work order budget.

• Monitor out-of-scope activities and follow through on change orders.

• Create and maintain project plans related to site activation.

• Contribute to SOPs, best practice guidelines, training, and coaching initiatives.

• Provide feedback for departmental process enhancement initiatives.

• Establish and interpret metrics related to site activation to drive corrective measures.

• Participate in proposals, budget preparation, and bid defense meetings.

• Report or escalate issues to the relevant Site Activation leadership.

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

• Coordinate with functional contributors and vendors.

• Perform additional tasks as assigned.

⛳️ Requirements

• A minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or a related scientific field, OR a two-year college degree or equivalent education/training (such as a nursing degree or comparable life science degree) along with experience in clinical research (e.g., CRA, Regulatory Affairs).

• At least 4 years of experience in the CRO/pharmaceutical industry, ideally in Start-up Management, Project Management, and/or Site Management.

• Strong skills in cross-cultural communication.

• Proficient in both spoken and written English.

• Knowledge of regulatory processes and guidelines.

• Understanding of the initiation, planning, and execution of clinical projects along with overall project management.

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

• Proficient in MS-Office applications, including Microsoft Word, Excel, and PowerPoint; aptitude for digital systems.

• Excellent leadership and organizational management capabilities.

• Ability to exercise good judgment, make independent decisions, and proactively identify and resolve issues.

• Capability to motivate, lead, and engage a team.

• Strong interpersonal, verbal, and written communication skills.

• Proven ability to collaborate across the organization.

• Capacity to manage multiple tasks in a fast-paced and ever-evolving environment.

• Skill in working in an organized, methodical, and self-driven manner.

🏝️ Benefits

• Competitive benefits package based on location.

• Transparent compensation and pay equity.