Operations Manager - Data Management/Biometrics

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Operations Manager position is responsible for oversight and successful delivery of assigned FSP partnership operations. The Operations Manager is responsible for ensuring that the assigned FSP programs are conducted within agreed program metrics and in accordance with the applicable SOPs and regulatory requirements.

Essential Functions:

• Ensures quality and successful delivery of the services provided by assigned FSP partnership staff across all development functions.
• Responsible for the supervision and line management of assigned direct reports within the assigned FSP partnership. This includes but is not limited to HR issues, work performance and work behavior issues, communication of work assignment changes, management of vacation time, leave of absence, and supervision of employment issues in connection with performance of the services.
• Acts as a point of contact for the client stakeholders including issue escalation and management.
• Knowledge, understanding and compliance with client processes and operating standards including alignment with metrics.
• Performs metrics collection and review with the client and ProPharma Group FSP partnership stakeholders.
• Identify individual soft skill training needs and assist in the conduct of the training and development efforts.
• Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams
• Develop and maintain effective relationships with management team to manage FSP staff in a matrix environment.
• Promote employee satisfaction and retention by ensuring ProPharma Group employees / contractors remain engaged and meet client requirements.
• Other duties as assigned.

Necessary Skills and Abilities:

• Effective communication, interpersonal and leadership skills with ability to partner with cross functional internal and external stakeholders.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Experience managing/mentoring and developing junior staff.
• Demonstrated experience in change management initiatives.
• Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.
• Proficiency in web-based systems and project management applications (e.g., Microsoft Office, SharePoint, etc.).
• Being able to follow and comply with assigned SOPs.
• Knowledge of ICH-GCP and applicable regulatory agency regulations.

Educational Requirements:

• Bachelor’s degree or advanced degree preferred. Candidates with equivalent combination of education, training, and experience will be considered.

Experience Requirements:

• 5 years of experience in clinical research preferred.