Senior Associate, Clinical Operations

Duration: 12 Months+

The Sr. Associate will support the Safety Alert Reporting team leadership in overseeing the quality of the team’s execution of the end-to-end process.

Primary responsibility will be identifying and escalating compliance risks to ensure we are always inspection ready.

Additional responsibilities include supporting the clinical team members throughout the duration of their studies, applying knowledge from relevant guidance documents and reporting requirements in day-to-day situations, and monitoring the safety alert reporting system activities.

Essential Functions

1. Oversight of the end-to-end process focusing on quality and inspection readiness 40%

• Serve as backup to the department head providing coverage in their absence.
• Perform quality control checks, provide guidance on corrections needed, and/or escalate issues for resolution.
• Monitor that the reporting timelines are adhered to in both the daily distribution and in issue resolution escalating as necessary.
• Suggest process improvements to improve compliance and quality while streamlining whenever possible.
• Serve as a point of contact for more advanced inquiries by the clinical team members escalating difficult or high-risk situations as needed
• Develop and maintain collaborative relationships with external parties including stakeholders, alliance partners, CROs, vendors, and study site staff by fostering a customer service mindset in personal work and throughout the team.
• Review of safety alert reporting regulations and guidelines, discuss impactful changes internally, and provide updates, guidance, and training to the affected parties as needed.
• Assist with the onboarding, training, and development of junior team members.

1. Support Safety Alert Reporting System functionality to ensure compliance and business needs are met 30%

• Raise questions and concerns in the weekly meetings with the vendor with a focus on feedback received from both a regulatory requirement and business needs perspective.
• Identify and escalate existing risks and/or performance issues and work with the vendor to resolve.
• Actively participate in all enhancement/improvement discussions raising questions or concerns around functionality and how it will impact existing processes as well as new requirements.
• Provide feedback to the department head on the performance of the system vendor and escalate any system issues.
• Performs system testing in the DEV/VAL/PROD environments or coaches junior team members with these tasks to ensure any code changes perform as expected and do not negatively impact existing user requirements.
• Manage the training and access requests of the study team members in accordance with Client’s SOPs.

1. Improve data sharing across Global Regulatory Clinical Services 20%

• Provide the TMF Management team with updates received from the clinical teams impacting key milestones or changes in clinical site staff to increase inspection readiness.
• Identifies shared data across functional teams within organization to collaborate on a future state single source of truth to improve accuracy, frequency, and quality of the data driving processes across the organization.
• Support the collaborative process across Global Regulatory Clinical Services to develop a single process to collect data from NBG/OBG Study Teams to support both Safety Alert Reporting and TMF Management.

1. Ongoing improvement of the Inspection Readiness of the department 10%

• Tracks, and appropriately escalates, KPI’s to measure compliance/non-compliance on a per study basis
• Continually monitor, and suggest improvements, on how to best communicate compliance risks both internally to team members and externally to the Clinical Team members to improve outcomes
• Work with the external PV consultant to ensure we are up to date on any regulatory changes globally, communicate the changes internally/externally and if needed work with the safety alert reporting system vendor to accommodate the change.
• Oversee ongoing inspection readiness initiatives and conduct lessons learned from findings if applicable
• Provide hands-on support to the department head during regulatory inspections

Requirements:

• Bachelor’s degree required
• 3-5 years of pharmaceutical experience, with a minimum of 1-2 of safety reporting/regulatory or relevant experience
• Must be able to perform root cause analysis
• Strong knowledge of regulatory guidance and/or regulatory intelligence
• Knowledge of safety report submission activities is a plus
• Strong computer skills, particularly with database/system’s/data management and troubleshooting
• Experience working with blinded/unblinded and/or sensitive and confidential documents
• Strong desire to learn and the ability to quickly grasp multiple skills simultaneously
• Strong proofreading, editing, and reviewing skills are required
• Must be detail oriented, highly organized, and quality driven
• Possess a strong work ethic and be able to work both as part of a team and independently
• Ability to delegate responsibility and assist with keeping the process moving through to successful completion
• Experience contributing to guidance documents (SOPs/SWPs/User Manuals etc.)
• Strong written, and verbal, communication skills

Shift: Day