Senior Project Manager - Global Medical Affairs

Unither Pharmaceuticals

32d • Hybrid

About The Position

The Senior Project Manager of Medical Affairs will independently provide oversight and coordinate the operational delivery of late phase clinical trials to ensure all study objectives are met, including adherence to required timelines, budget, quality, and performance expectations. This role ensures successful planning and completion of assigned projects, including clinical studies, registries, or other strategic study/departmental initiatives. Lead operations of clinical trial(s) from study start-up to close-out including ensuring study conducted in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations, and developing new SOPs as needed; coordinating and managing resources assigned to the study; and managing study budget, timelines, quality and performance expectations Serve as primary contact during clinical study/project, including regular collaboration, conferences calls and team meetings with appropriate functional areas, management and vendors as necessary Support insourcing/outsourcing partners to ensure they meet the required standards and expectations Significantly contribute to study concept, protocol, clinical study report as well as other critical study documents as required Lead vendor management, inclusive of selection, negotiation, implementation and management of vendor’s Statements of Work/Scope of Work (SOW) Plan, manage and report on all strategic study initiatives through oversight of cross-functional study activities; provide regular study updates to project team leads/senior management, if applicable Identify, resolve or escalate risks and issues involving study timelines and deliverables Establish, collect, track and report Key Performance Indicators (KPIs) such as query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc. to company stakeholders Collaborate with team to ensure adequate protocol related and process training of all study team members; manage protocol deviations/violations to ensure proper documentation and proactively work with Investigative sites to reduce their occurrence Assist with preparation for interim and primary analysis reports, as applicable Participate in the development and refinement of relevant policies, guidelines, and SOPs Support the identification, contracting, and management of study-related steering/advisory committees Collaborate with clinical operations and other relevant functional groups (UT and / or CRO) to manage and engage with clinical study sites, ensuring milestone adherence Contribute to the development of study publication plans and review/preparation of study abstracts, manuscripts, etc. Provide first tier support for protocol, SOP and system questions; may serve as point of escalation for other project managers, if applicable Evaluate current processes for efficiencies and quality as well as make recommendations for improvements, as applicable Participate in departmental strategic planning sessions/initiatives, providing input from a project management/study operations perspective, as applicable

Requirements

• Bachelor’s Degree
• 5+ years of project management experience in clinical operations management, overseeing clinical trials in pharmaceutical environment or related experience or 5+ years of related project management experience in clinical research/pharmaceutical industry
• General therapeutic area education and training
• Ability to interact and communicate effectively, both verbally and in writing, both within and outside clinical operations, with upper management, Key Opinion Leaders, vendor personnel, and clinical investigators and site personnel
• Strong working knowledge of GCP/ICH regulations and guidelines
• Strong overall scientific and clinical/medical research background
• Experience with EDC and CTMS systems
• Experience and comfort in working both independently and as part of a cross-functional team
• Commitment and ability to handle high workloads, demanding situations, and deadlines
• Ability to proactively identify potential issues and formulate potential course(s) of action
• Proficiency with MS Office Suite, including Word, Excel, PowerPoint, and Outlook
• Ability to travel up to 30%

Nice To Haves

• Master’s Degree in scientific discipline (MPH, MA/MS)
• Certified Project Management Professional (PMP)-PMI
• Proficient in Microsoft Project, SmartSheet, and Electronic Data Capture (EDC) systems
• Previous experience with all phases of clinical research
• Demonstrated leadership experience as evidenced by the ability to motivate teams, provide advanced planning analysis, provide strategic guidance by evaluating risks against departmental deliverables

Responsibilities

• Lead operations of clinical trial(s) from study start-up to close-out including ensuring study conducted in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations, and developing new SOPs as needed; coordinating and managing resources assigned to the study; and managing study budget, timelines, quality and performance expectations
• Serve as primary contact during clinical study/project, including regular collaboration, conferences calls and team meetings with appropriate functional areas, management and vendors as necessary
• Support insourcing/outsourcing partners to ensure they meet the required standards and expectations
• Significantly contribute to study concept, protocol, clinical study report as well as other critical study documents as required
• Lead vendor management, inclusive of selection, negotiation, implementation and management of vendor’s Statements of Work/Scope of Work (SOW)
• Plan, manage and report on all strategic study initiatives through oversight of cross-functional study activities; provide regular study updates to project team leads/senior management, if applicable
• Identify, resolve or escalate risks and issues involving study timelines and deliverables
• Establish, collect, track and report Key Performance Indicators (KPIs) such as query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc. to company stakeholders
• Collaborate with team to ensure adequate protocol related and process training of all study team members; manage protocol deviations/violations to ensure proper documentation and proactively work with Investigative sites to reduce their occurrence
• Assist with preparation for interim and primary analysis reports, as applicable
• Participate in the development and refinement of relevant policies, guidelines, and SOPs
• Support the identification, contracting, and management of study-related steering/advisory committees
• Collaborate with clinical operations and other relevant functional groups (UT and / or CRO) to manage and engage with clinical study sites, ensuring milestone adherence
• Contribute to the development of study publication plans and review/preparation of study abstracts, manuscripts, etc.
• Provide first tier support for protocol, SOP and system questions; may serve as point of escalation for other project managers, if applicable
• Evaluate current processes for efficiencies and quality as well as make recommendations for improvements, as applicable
• Participate in departmental strategic planning sessions/initiatives, providing input from a project management/study operations perspective, as applicable

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees