Manager, Clinical Business Operations

Clinical Business Operations Manager

Reports to Head of Global Clinical Operations

Opportunity

The Clinical Business Operations Manager is a strategic role within the R&D GCO organization, dedicated to driving operational excellence across clinical trials. The Clinical Business Operations Manager (CBOM) acts as a primary point of contact for all vendors and GCO business partners for their therapeutic & functional areas of support across the portfolio. CBOM will collaborate with clinical program directors, clinical program leads, clinical trial leads, finance, procurement & strategic sourcing, legal, and other internal stakeholders to secure services for our clinical trials and drive the governance and overall management of their scope of work.

Responsibilities

• Influences and strategically manages the linkages between GCO across functional areas, including finance, project management, data management, PK, biostatistics, clinical development, medical affairs, regulatory, drug supply, pharmacovigilance, translational, CMC, and QA to drive the successful implementation of the outsourcing strategy for an assigned project or program
• Work closely with Finance and clinical program team to closely monitor scope of work, vendor budgets, out-of-scope activities, accrued units or milestones, and tracking of vendor payments.
• Acts as the first line of contact for issue escalation related to contracts and budgets.
• Provides training of internal stakeholders on key contractual terms and obligations to ensure compliance and understanding as the business partners execute the work performed under the contract
• May independently lead the RFP and RFI process, analyze supplier services, budgets and proposals, conduct bid defense meetings, award vendors, negotiate and execute complex agreements
• Cultivate and maintain strategic partnerships with Contract Research Organizations (CROs) and other vendors to optimize timelines, budgets, and quality across the portfolio.
• Independently identifies, escalates and manages non-preferred provider vendor performance issues and develops and implements solutions to ensure overall performance, compliance, and quality.
• Partner with functional leaders to drive alignment across the clinical trial portfolio, ensuring strategic priorities are consistently met.
• Driving a culture of innovation and operational excellence, ensuring the clinical operations function remains at the forefront of industry’s best practices and emerging trends.
• Provide effective communication and recommendations to the business with support from the SME to ensure Menarini Stemline receives the best value for the contracted service. Accountable for the development and successful execution of the contract implementation plan which includes implementing the sourcing strategy to ensure timelines are met while maintaining compliance with all applicable policies and procedures.
• Actively monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization utilizing advanced knowledge to drive the negotiation of the change orders and associated costs to minimize the risk to Menarini Stemline. Manages expectations and mitigates risk by providing strategic solutions for issues and executes final agreements/change orders with minimal guidance and support.
• May lead or contribute as a subject matter expert on key projects, initiatives, and committees including governance vendor meetings to identify and implement process improvements and standards while ensuring Menarini Stemline’s business needs and purchasing/compliance requirements are met.
• May oversee the selection, implementation, and management of key clinical technologies (e.g., project accounting tool.

Qualifications

• BA/BS or equivalent related work experience is required; Degree in healthcare, legal and/or finance preferred.
• Minimum 6 years of extensive experience in research, industry or legal setting with pharmaceutical industry experience in clinical outsourcing contracting or finance is required.
• Must have demonstrated ability in negotiation and project management skills with the ability to coordinate across projects/program/timelines. Must have superior written and oral communication skills, with the ability to convey overall engagement objectives and maintain open lines of communication between the internal stakeholders and the service providers.
• Ability to build internal and external relationships to effectively and independently provide leadership and mentor other team members to strategically drive the business and solve issues efficiently and mitigate risk.

Skill/Knowledge Requirements

• Proven experience selecting and managing, and overseeing CROs, vendors, and clinical trial consultants.
• Demonstrated expertise in forecasting, budgeting, data analytics, modeling, and process improvement design.
• Strong project management skills and the ability to lead cross-functional teams in a matrixed environment.
• Experience with technology implementation and operational transformation within clinical trials.
• Demonstrated success in scaling operations within a fast-paced, entrepreneurial biotech or pharmaceutical setting.
• Strong analytical skills with the ability to synthesize complex data and communicate actionable insights.
• strong interpersonal skills with demonstrated ability to connect, collaborate and build relationships across all levels and functions and establish credibility with leaders and key external stakeholders
• strong oral and written communication skills with ability to communicate effectively at all levels and present complex and/or new ideas both internally and with external stakeholders
• extensive knowledge of GCP and ICH principles of clinical trial conduct
• strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint).

Stemline Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.