Manager, Clinical Business Operations

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

As we continue to grow, we are seeking a Manager of Clinical Business Operations to join the US Pharmaceuticals team.

Scope of the role:

The Manager, Clinical Business Operations, is primarily responsible for managing and negotiating clinical contracts ensuring contracts are properly maintained, monitored and compliant with regulations.  The Manager collaborates cross-functionally with Clinical Operations, Legal, Finance, and Procurement teams aligning contracts with business objectives and regulatory requirements.  The Manager may also be involved with invoice review and monthly financial reconciliation reviews.

The Manager will also contribute to contract process improvements and systems implementations. 

Your key responsibilities:

-             Responsible for managing and negotiating vendor contracts and change orders

-             Coordinates with key internal stakeholders to ensure vendor contracts and change orders are approved and executed in a timely manner

-             Ensure timely receipt and processing of invoices by CBO

-             Ensure timely review and approval of invoices by R&D contract owners

-             Ensure payments are issued in accordance with contract terms and conditions

-             Assists R&D contract owners with resolution of invoice disputes

-             Maintain required documentation related to invoices and payments

-             Raise, amend, reconcile and close out new and/or existing POs

-             Collaborate with FP&A with monthly close (accruals) and LE (forecasting) processes

-             Support internal stakeholders throughout the Development organization and corporate support functions, including but not limited to FP&A, AP, Procurement, Legal, Clinical Operations and other Development functions; and external vendors, consultants, investigators and clinical trial sites

-             Other financial and administrative tasks as needed

-             May supervise 1 or more direct reports

-             Understands the legal and compliance environment and able to successfully drive collaboration with the Legal and Compliance team

Who you are:

-             Bachelor's degree in a scientific or health-related field is required;  Master’s degree preferred

-             Ability to travel up to 15% of the time, including overnight and weekend travel and in some cases, internationally

-             8+ years of accounting/billing/payment/vendor management/contracting experience, preferably in a biopharma R&D organization

-             Proven experience with clinical project budgets, vendor management activities, and vendor contracts

-             Excellent computer literacy, strong proficiency in Microsoft Excel, Word and Outlook, and ability to learn new software/systems (e.g., contract management systems, financial systems, etc.)

-             Clinical Operations Expertise: Significant experience managing clinical project budgets, vendor relationships, and contract negotiations, including outsourcing of large, global, multi-center studies

-             Financial & Contractual Proficiency: Strong working knowledge of contracts, invoicing, and payment processes, with a focus on accuracy and compliance

-             Customer Service & Communication: Excellent interpersonal skills with strong customer service orientation. Demonstrates a professional demeanor and effective communication across multidisciplinary teams

-             Organizational Strength: Highly organized, detail-oriented, and flexible, with the ability to manage multiple priorities and adapt to changing demands

-             Results-driven with strong problem-solving skills

-             Regulatory Knowledge: Solid understanding of GCP, ICH guidelines, and FDA regulations. Familiarity with EMA/CHMP and other international regulatory requirements is a plus

-             Line Management: Proven ability to mentor and manage effectively and within a matrixed organization

-             Global Study Execution: In-depth understanding of cross-functional responsibilities in clinical trial design, global study start-up and execution, CRA and site management, biometrics, and database lock through data analysis

-             Technical proficiency: Familiarity with contract management systems, electronic document systems (eg eTMF) and data analysis tools to enhance operational efficiency

-             Ability to work across time zone differences and cultural differences

-             A strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.

Compensation & Benefits:

The anticipated salary range for this position is $145,000 to $165,000. This represents the anticipated low and high end of the salary range for this position.  Actual salaries may vary based on various factors including, but not limited to, experience, skillset, and performance. 

The salary range listed is just one component of our total compensation package.  Alfasigma US also provides a competitive suite of benefits, including:

•     401(k) plan with company match

•     Rewards and recognition program

•     Health care benefits (medical, prescription drugs, dental, and vision insurance)

•     Short and long-term disability coverage provided

•     Plan coverage for domestic partners

•     Paid parental leave benefits and adoption assistance

•     Tuition reimbursement assistance

•     A generous Paid Time Off program that includes 20 vacation days, 11 holidays, 4 personal days, and 2 volunteer days per calendar year

•     Numerous well-being and work/life programs

EEO Statement

Employment decisions at the Company are made without unlawful regard to race, color, religion, creed, national origin, alienage or citizenship status, sex (including gender, pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, sexual orientation, national origin, ethnicity, age, physical or mental disability, legally protected genetic information, marital or partnership status, sexual and reproductive health decisions, military or veteran status, or any other status protected by applicable federal, state, or local law. This organization participates in E-Verify (E-Verify's Right to Work guidance can be found here:  https://www.e-verify.gov/sites/default/files/everify/posters/IER_RighttoWorkPoster.pdf).