PV Coordinator, Senior PV Coordinator

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

📋 Description

• Facilitate timely evaluation of protocol inquiries, both serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board data.

• Monitor required data and create reports for clients, project teams, and external vendors.

• Represent the DSMB/EAC Coordination Team during global and domestic committee meetings via teleconferencing and in-person sessions.

• Organize meeting logistics and assist with facilitation efforts.

• Collaborate with internal and external stakeholders to execute projects.

• Prepare and coordinate the approval of Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements.

• Compile adjudication dossiers and follow up with investigative sites.

• Coordinate and lead project meetings, draft minutes, and distribute meeting materials.

• Upload blinded and unblinded minutes/materials to client portals.

• Oversee project-specific training and manage program file setup, maintenance, and archival.

• Identify and redact subject identifiers, retrain sites, and escalate recurring issues to Data Privacy.

• Execute data entry and system reconciliations to pinpoint issues impacting project timelines.

• Supervise expenses and manage translations within budget constraints.

• Assist with specific activities conducted by the local office that are not feasible elsewhere.

• Provide training to junior staff members.

⛳️ Requirements

• High/Secondary school diploma or equivalent along with relevant formal academic or vocational qualifications.

• Technical roles may necessitate a certificate.

• A minimum of 2 years of relevant experience, aligning with the knowledge, skills, and abilities required for this position.

• A combination of suitable education, training, and/or directly related experience may be deemed adequate as an equivalency.

• Strong problem-solving abilities.

• Capability to work independently with minimal supervision.

• Proficiency in building strong relationships.

• Ability to analyze project-specific data and systems for accuracy and efficiency.

• Skill in communicating respectably and diplomatically with clients, management, project team members, and internal staff.

• Effective oral and written communication and interpersonal skills.

• Excellent computer proficiency, including MS Office (Word, Excel, PowerPoint, Access).

• Ability to prioritize and manage multiple tasks simultaneously under tight deadlines.

• Strong attention to detail and precision.

• Ability to maintain a positive and professional demeanor in challenging situations.

• Flexibility to adjust workload priorities as project timelines evolve.

• Working knowledge of relevant FDA Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs for the implementation, execution, and closeout of non-clinical and clinical projects.

🏝️ Benefits

• Fully remote work opportunity.

• Standard work schedule from Monday to Friday.

• Opportunities for training and development, including providing training to junior staff.

• Potential benefits and privileges associated with employment.

• Reasonable accommodations for individuals with disabilities.

• Equal employment opportunities and non-discrimination.