WEP Clinical

• Responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities. • Oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements. • Act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

• The WEP Clinical Senior Clinical Research Associate (Senior CRA) oversees all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs. • They conduct on-site and remote monitoring to ensure protocol adherence, maintain essential documentation, and keep site and patient data inspection-ready. • The Senior CRA builds strong relationships with sponsors and sites, serving as a key point of contact throughout the study. • They may also support development of study-specific procedures (e.g., Monitoring Plans) and assist in training or coordinating other CRAs.

• Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV). • Contribute to the development of protocols, study tools, materials, and documentation for clinical sites. • Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed. • Review site-level investigational drug accountability and safety event documentation. • Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required. • Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan. • Manage query resolution. • Provide mentoring, training, and co-monitoring of junior team members. • Assist in the development of applicable WEP Clinical Standard Operating Procedures. • Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs. • Complete, review, and/or submit monitoring reports and query logs. • Address protocol or monitoring-related questions received from clinical sites for assigned programs.

• Collaborate with Clinical Operations to develop site initiation timelines and ensure adherence to project milestones • Prepare and manage site startup documentation, including contracts, informed consent forms, and regulatory submissions • Coordinate with contracts and budget teams to ensure timely execution of site agreements • Assist with the preparation and submission of essential regulatory documents for site activation • Ensure all documents are approved by ethics committees and IRBs before site activation • Track progress of regulatory submissions, site contracts, and essential document collection • Verify site readiness with adequate resources and completed training prior to patient enrolment • Participate in study kick-off and initiation meetings to align expectations and timelines • Troubleshoot activation issues and escalate problems to the Project Manager or CRA when needed • Assist with the setup of study supplies and equipment at the site, including investigational products and lab kits

• Provide high-quality nursing care to clinical trial participants in their homes • Perform study-related procedures, including but not limited to: - Vital signs - Specimen collection, processing, and shipment - Electrocardiograms (ECGs) - Process specimens and ship specimens per protocol. • Administer investigational medications/products per study protocol • Conduct patient assessments and monitor for adverse events; report findings to the study team/Principal Investigator • Accurately document all visit activities in accordance with study requirements • Educate patients on study procedures, medications, and compliance • Maintain adherence to ICH-GCP guidelines and study protocols • Communicate effectively with patients, caregivers, and study teams • Maintain strict adherence to HIPAA and all applicable patient privacy regulations, ensuring secure handling and confidentiality of protected health information (PHI)

• Provide high-quality nursing care to clinical trial participants in their homes • Perform study-related procedures, including but not limited to: - Vital signs - Specimen collection, processing, and shipment - Electrocardiograms (ECGs) - Administer investigational medications/products per study protocol • Conduct patient assessments and monitor for adverse events; report findings to the study team/Principal Investigator • Accurately document all visit activities in accordance with study requirements • Educate patients on study procedures, medications, and compliance • Maintain adherence to ICH-GCP guidelines and study protocols

• The Clinical Project Manager at WEP Clinical is responsible for the setup, implementation, and management of clinical trials, ensuring patient safety, data integrity, and high-quality delivery in compliance with applicable regulations. • This role provides leadership across cross-functional teams, manages client relationships, and is accountable for delivering clinical trials on time, within scope, and within budget.

• Develop and implement annual marketing plans aligned with company growth objectives. • Support brand positioning and market differentiation within the CRO and life sciences sector. • Create and execute lead generation campaigns targeting pharmaceutical, biotech, and medical device companies. • Support sales and business development teams with marketing collateral, presentations, and campaign assets. • Manage marketing-qualified lead (MQL) generation and nurture campaigns through CRM and marketing automation platforms. • Manage digital campaigns including LinkedIn advertising, webinars, and content syndication. • Oversee website content, SEO/SEM strategy, email marketing, and social media activity. • Develop high-quality marketing content including: • Case studies • White papers • Brochures • Thought leadership articles • Conference materials • Website and email content. • Manage participation in industry conferences, trade shows, and networking events. • Coordinate event logistics, promotional materials, and post-event follow-up campaigns. • Ensure consistent corporate branding across all internal and external communications. • Monitor marketing KPIs including lead generation, campaign performance, website analytics, and engagement metrics.

• Develop and implement annual marketing plans aligned with company growth objectives. • Support brand positioning and market differentiation within the CRO and life sciences sector. • Create and execute lead generation campaigns targeting pharmaceutical, biotech, and medical device companies. • Support sales and business development teams with marketing collateral, presentations, and campaign assets. • Manage marketing-qualified lead (MQL) generation and nurture campaigns through CRM and marketing automation platforms. • Manage digital campaigns including LinkedIn advertising, webinars, and content syndication. • Oversee website content, SEO/SEM strategy, email marketing, and social media activity. • Develop high-quality marketing content including: - Case studies - White papers - Brochures - Thought leadership articles - Conference materials - Website and email content. • Manage participation in industry conferences, trade shows, and networking events. • Coordinate event logistics, promotional materials, and post-event follow-up campaigns. • Ensure consistent corporate branding across all internal and external communications. • Monitor marketing KPIs including lead generation, campaign performance, website analytics, and engagement metrics.

• Drive growth of the commercial pipeline by identifying and engaging potential clients through CRM tools, networking, cold calling, and digital marketing. • Record and report deal progression and sales activity through WEP’s CRM system. • Conduct outside sales activities to generate new opportunities. • Evaluate and report on new business opportunities, market conditions, and competitor activities to help drive revenue growth and improve margins. • Prepare and present account updates, sales results, and lead generation status to management. • Collaborate with the broader Business Development team to prepare for meetings and conferences. • Attend conferences and trade shows to professionally represent WEP Clinical and uncover new business opportunities. • Partner with internal teams to develop client solutions. • Support proposals and pricing efforts, along with other Business Development activities, as required.