Senior Manager, Clinical Operations
Job description
About the role
Adams Clinical invites applications for a Senior Manager, Clinical Operations position at the Watertown site. This role operates full-time and focuses on directing day to day site operations while leading multiple study teams. You will own the full study lifecycle from first contact to final closeout. Decisions on scope, staffing, and risk belong to you here. Teams move faster when you remove blockers and keep momentum. You will uphold the values of Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration in every action you take.
Key facts
What you'll do
You will serve as the primary point of contact for day to day site issues across all study activities. You will monitor study operations, enrollment progress, visit schedules, and site performance metrics for both inpatient and outpatient studies. You will actively support subject recruitment, eligibility assessments, and randomization processes while overseeing study workflows. Documentation will adhere strictly to ALCOA standards, and you will manage study trackers and investigational product handling with precision. You will ensure proper handling of participant safety events and adverse event reporting, including SAE and AESI processes with timely execution. You will identify operational, regulatory, or safety risks early and implement mitigation strategies alongside senior leadership. Critical issues will be escalated promptly to maintain study integrity and compliance. You will work closely with the Inpatient Unit Manager and the Associate Director of Inpatient Clinical Operations to coordinate care. This collaboration will support and oversee the conduct and quality of all inpatient studies at the Watertown inpatient facility. You will ensure alignment on workflows, study execution, and safety practices within the inpatient unit on a daily basis.
You will collaborate with Finance to review Clinical Trial Agreement invoicing and ensure accuracy. You will oversee participant reimbursement processes while supporting site level budget monitoring and forecasting activities. You will build review routines that catch documentation gaps before audits arrive to prevent delays. You will coordinate partner playbooks so that sites and vendors align on timelines, roles, and handoffs seamlessly. You will ship operational dashboards that turn complex metrics into clear action signals for decision makers. You will champion compliance by maintaining ALCOA records and SAE and AESI reporting discipline rigorously. You will drive standardization across site processes to improve efficiency and reduce variability. You will facilitate cross functional communication to ensure study timelines are realistic and achievable. You will provide mentorship to junior team members to strengthen the overall operational capacity. You will translate sponsor requirements into actionable site processes that are both compliant and practical.
Requirements
You bring one and a half years of clinical operations experience in trials within a regulated environment. You understand inpatient and outpatient workflows and regulatory expectations deeply. You manage documentation with rigor so data stays organized, traceable, and retrievable at all times. You communicate clearly with sponsors, finance, and clinical teams under pressure without compromising quality. You demonstrate strong attention to detail while balancing multiple priorities and deadlines simultaneously. You are comfortable making decisions within defined governance frameworks and escalation paths. You exhibit ownership of complex operational problems and follow through to successful resolution. You use structured problem solving to address gaps in processes or system failures effectively.
Nice to have
Experience in collaborative environments where transparency drives decisions is valued highly for this role.
Tools and skills
You will use Microsoft Office on a regular basis for documentation and reporting tasks. You will work with Adobe Acrobat, Salesforce, and a CTMS to manage study activities efficiently. Proficiency with Veeva Vault is expected for data management and records. You will use Jira and Slack for communication and task tracking to maintain visibility. You will navigate electronic systems with ease to ensure study progress is transparent and accurate. You will leverage analytical skills to interpret performance metrics and drive improvements. You will apply knowledge of clinical trial regulations to support compliant study execution. You will utilize problem solving abilities to troubleshoot operational challenges as they arise.
Practical notes
The appointment is contingent on experience, with a baseline of one and a half years clinical operations experience in trials. Please note that this is a full-time role based in Watertown, Massachusetts, United States. Before proceeding, ensure that your eligibility aligns with the requirements outlined in the source details.
What you'll do
- Meet the bar