Clinical Operations Manager US

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

• Access – Providing high quality trusted medicines regardless of geography or circumstance;

• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 

• Partnership – Leveraging our collective expertise to connect people to products and services. 

Every day, we rise to the challenge to make a difference and here’s how the Clinical Operations Manager US role will make an impact:

Key responsibilities for this role include:

• Manage the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licenses for materials and IMP, eTMF sat-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards (ECs/IRBs), timely completion of electronic Case report Forms (eCRFs), Source Data verification (SDV) progress and query responses timelines.

• Manage the selection of ESPs in collaboration with other functions.

• Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables.

• Supervise the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to the Clinical Trial team (CTI).

• Lead the development of trial-related operational documents.

• Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators).

• Resolve operational issues in a proactive and timely fashion.

• Act as the communication channel for the Clinical Research Associates (CRAs) to ensure data quality is maintained, in close collaboration with other CTT functions

• Approve invoices (e.g., site payments) and ensure related payments in a timely manner.

• Contribute to the Study Master File (StMF) completeness and readiness for audit/inspection and by performing ongoing quality checks/review.

• Actively participate to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary.

• Mentor team member as needed.

The minimum qualifications for this role are:

• Minimum of a bachelor’s degree in life sciences or healthcare (or equivalent) and 4-7 years of experience.  However, a combination of experience and/or education will be taken into consideration. 

• 4 years of experience in managing operational aspects of Phase II and Phase Ill trials and executing a wide range of clinical trial activities from study start up to clinical study report.

• Experience in working in global cross-functional (matrix) and multicultural teams.

• Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.

• Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).

• Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.

• Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint).

• Excellent verbal and written communication skills in English; strong cultural knowledge of national diversities.

• Position may require international travel.

• Strong interpersonal, communication (written and verbal), collaboration and organizational skills.

• Self-motivated and able to work independently and proactively.

• Goal-oriented, able to effectively prioritize and execute tasks in a high-pressure environment.

• Demonstrate ownership and initiative, decision-making, working flexibility and problem-solving skills.

• Demonstrate ability to work in multi-functional and cross-functional teams: effective teamwork and collaborative relationships.

• Able to share expertise and experience with team members and across teams.

• Position functions autonomously. No direct reports.

• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.  Ability to work with managers or directors and communicate ambiguous concepts.  Ability to present to groups across the organization.

• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.  Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

• Periodic travel is required / International travel may be required.

• Proficiency in speaking, comprehending, reading and writing English is required.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $78,000.00 - $152,000.00 USD.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.