Senior Manager, Americas Start Up

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

1d•Onsite

About The Position

This role is designed for an individual who is not only experienced in site start-up but who is energized by creating, shaping, and optimizing the U.S. Site Start-Up operational model for EMD Serono. As Country Start-Up Manager, you will play a key role in defining U.S. processes, aligning with global standards, and establishing the practices and expectations that will guide future site start-up teams. This is an exceptional opportunity for a seasoned site start-up specialist who thrives in environments of innovation and operational design. You will work closely with global start-up leads, contribute to building future-state workflows, and elevate how we activate sites across the United States. If you are looking to design, influence, lead, and build, this role offers the opportunity to shape the future of U.S. clinical trial start-up operations from the ground up.

Requirements

Bachelor’s degree in a science-related field or legal discipline with 5+ of experience in clinical research start-up, site activation, or clinical monitoring roles.
OR
Masters degree in a science-related field or legal discipline with 3+ of experience in clinical research start-up, site activation, or clinical monitoring roles.
Contract and budget negotiation experience required.
Experience working in high-volume, complex operational environments.

Nice To Haves

Strong adaptability, critical thinking, and communication skills.
Comfort working independently while thriving within a global matrix.
Excellent planning, time management, and organizational capabilities.
Expertise across systems such as Microsoft Office, Adobe Acrobat, CTMS, Veeva, eTMF, SharePoint, and document management platforms.
Strong knowledge of ICH-GCP and U.S. regulatory expectations.
Ability to mentor, guide, and influence others—ideal for those seeking leadership growth.
Highly proactive, organized, confidential, and accountable.

Responsibilities

Lead timely, high-quality execution of all start-up activities at the U.S. country/cluster level—from EC/IRB submissions through site activation.
Serve as the primary site-facing point of contact for all U.S. Site Start-Up activities.
Manage and compile submission documentation: regulatory packages, confidentiality agreements, feasibility questionnaires, amendments, and site notifications.
Review, adapt, and approve essential documents, including U.S. ICFs (initial and amended), to ensure accuracy and compliance.
Identify risks early and define mitigation strategies to ensure activation timelines are met.
Manage communications with regulatory authorities and EC/IRBs through approval.
Coordinate EC/IRB payments and fees with internal financial teams.
Prepare Regulatory Green Light / IP Release Packages and ensure timely review and release.
Perform site handover to CRAs post‑activation, ensuring all risks and outstanding items are documented and communicated.
Track, forecast, and report start-up progress to U.S. and global stakeholders.
Maintain all documentation and tracking systems (CTMS, eTMF, databases) in a compliant, accurate, and current state.
Draft, negotiate, and execute Clinical Study Agreements, site budgets, and site-level amendments.
Serve as the U.S. subject matter expert for contract and budget activities.
Negotiate legal and financial terms, aligning site budgets with local FMV and U.S. regulatory requirements.
Draft and execute ancillary agreements (PI/Sub‑I/department), as applicable.
Support selection and alignment of appropriate signing parties based on U.S. requirements (tax/VAT/R&D/WHT considerations).
Ensure contract status is accurately tracked in CTMS and appropriate repositories.
Proactively identify contract‑related risks and escalate to Global Contract Leads as needed.
Drive quality, consistency, and efficiency of site activation across all U.S. studies within the EMD Serono portfolio.
Play a central role in designing, optimizing, and implementing U.S.-specific site start-up workflows and processes.
Enable adoption of innovative technologies, automation, and solutions that advance study start-up performance.
Directly influence the speed at which new therapies can move through clinical development and reach patients.