|Sunrise Systems Inc|
US-Nationwide, Associate Director
Role: Associate Director
Location: Work from Home
Duration: 3+ Years Contract to Begin With
Type: Hourly Contract Opportunity (W2 Based)
· The Associate Director, Site Management Operations, Program Lead is responsible for leading internal and outsourced site management & monitoring personnel and activities in support of clinical research studies.
· The Associate Director is accountable for all site management integrity, quality, and timeliness of monitoring activities.
· Responsibilities include facilitating & maintaining the protocol risk assessment & characterization (PRAC), oversight and approval of protocol‐specific monitoring plans (PSMP), coordination of risk‐based monitoring activities including leading issue management meetings, audit responses, inspection readiness activities, and representing Global Site Management Operations (GSMO) in sponsor inspection activities.
· Other responsibilities include contribution to the protocol, case report forms & edit specifications, site profile, site feasibility questionnaire, & recruitment plan. Functions as the assigned GSMO representative to clinical trial teams (CTT) as well as the staff assigned to support studies including Lead Site Managers (LSM) and Contract Research Organization (CRO) Monitoring Leads (CML). Supports development and implementation of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs).
· The Program Lead must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
Key Duties / Responsibilities:
· GSMO Program Lead: Responsible for the role which includes the management and oversight of site monitoring deliverables and interfacing with CTTs on all aspects of study execution.
· Leads cross‐functional efforts to identify and manage study and site‐level risks and to identify and implement risk mitigation strategies.
· Escalates issues and risks to Senior Management as appropriate.
· Ensures that GSMO Staff (Regional Operations Managers (ROMs) and Regional Site Managers (RSMs)) are implementing site‐level risk mitigation strategies.
· Provides leadership and content expertise for site management and monitoring activities from study startup through the study closeout stage of clinical studies to effectively oversee resources, timelines, quality, and data delivery supporting database lock activities including:
• Site selection & activation
• Site recruitment
• Protocol compliance, safety reporting, & data quality
• Timely data entry and query management
• Action item resolution
• Adherence to PSMP
• Protocol risk assessment & issue management
• Oversight of key risk indicators
• Adherence to industry regulations, guidelines, & Allergan processes (SOPs & WIs)
• Maintain study and site inspection readiness at all times
• Provides status reporting on GSMO deliverables to Senior Management and Cross‐functional Groups
• May participate in due diligence activities related to mergers & acquisitions.
· In addition, the Associate Director is the key contact for Feasibility Analytics in Clinical Trials (FACT), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Clinical Data Management & Programming (CDMP), Global Patient Safety & Epidemiology (GPSE), Global Clinical Supplies Management (GCSM), Clinical Development, and Non‐Translational Sciences (NTS) as applicable related to Site Management & Monitoring on assigned studies.
· External Vendor / Outsourcing Management
· Responsibilities include participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in collaboration with the CTT and in accordance with applicable Allergan processes and procedures for assigned studies. Involvement in assessment/re‐assessment of vendor capabilities, as necessary. May participate in bid defense meetings & scope of work review.
· Accountable for supervising CRO oversight for assigned outsourced studies; responsible for ensuring the
· assigned CML conducts all oversight activities as related to site management & monitoring and properly
· escalates issues related to CRO monitoring activities; ensures CRO oversight is conducted consistently across all programs.
· In addition, the Associate Director is the key contact for R&D Sourcing and Clinical Vendor Oversight (CVO) related to Site Management & Monitoring and CRO oversight on assigned studies.
· Process Owner/Subject Matter Expert Responsibilities include the implementation of quality, efficient, and consistent approaches to carrying out site management & monitoring tasks. Drives and contributes to continuous improvement. Delivers training to GSMO and other functions/departments as necessary. Provides mentoring and support to new Program Leads.
· Monitors GSMO compliance with SOPs and WIs and proactively addresses gaps in processes or misunderstanding of processes.
· Supports Corrective and Preventative (CAPA) Action initiatives as needed.
· May be the CAPA Lead where necessary.
· In addition, the Associate Director is the key contact for Process, Training, and Continuous Improvement (PTCI) and Global Research & Development Quality (GRDQ) related to issues with site management & monitoring on assigned studies.
· Bachelor’s Degree with relevant work experience in Clinical Research, Allied Health, Project Management or related life science field.
· Significant clinical research experience within a site management operations & monitoring leadership role in the pharmaceutical/device industry or CRO (preferably within a medium/ large CRO).
· Advanced knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting).
· Advanced knowledge and understanding of project management guidelines & related concepts including experience managing large global projects.
· Advanced knowledge of global standards related to site management & monitoring activities (institutional review board or ethics committee reporting requirements, local regulations, risk‐based monitoring practices).
· Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization from a field‐based office location including home‐based office.
· Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment.
· Demonstrates excellent negotiation skills, innovating thinking & a solution oriented approach to problem solving and a “can do” attitude.
· Ability to travel overnight up to 30% of time. Must be able to maintain the necessary travel documents (e.g. valid driver’s license, passport, visa). May be required to lift more than 25 pounds, in association with travel requirements. Must maintain a credit limit that would support routine business travel expenses.
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