Manager, Study Start Up

Alkermes

18h•$140,000 - $155,000

About The Position

The Manager, Study Start-Up (SSU) is responsible for leading and overseeing all study feasibility, site start-up, and early enrollment activities to ensure timely and high-quality study activation. This role partners cross-functionally with Clinical Operations, CROs, and external vendors to deliver start-up milestones in alignment with study timelines, quality standards, and regulatory requirements. The SSU Manager proactively identifies risks, implements mitigation strategies, and applies industry best practices to optimize site engagement and enrollment performance.

Requirements

Bachelor’s degree required (life sciences or related field preferred).
Minimum of 8 years of experience in the pharmaceutical, biotechnology, or clinical research industry, with significant hands-on experience in study and site start-up.
Experience supporting global clinical trials; Phase I–IV experience required, CNS therapeutic area experience preferred.
Strong knowledge of clinical trial operations, ICH-GCP, and applicable regulatory requirements.
Demonstrated experience developing and using metrics and KPIs to monitor study progress and vendor performance.
Proven ability to manage complex activities in a fast-paced, matrixed environment while balancing multiple priorities.
Excellent written and verbal communication skills with the ability to influence and collaborate effectively across functions and with external partners.
Strong problem-solving skills with a proactive, solutions-oriented mindset.

Nice To Haves

CNS therapeutic area experience preferred.

Responsibilities

Lead study feasibility assessments, site identification, and country/site activation strategies in collaboration with Clinical Study Teams and CRO partners.
Develop, review, and maintain integrated study start-up plans, timelines, and enrollment forecasts; track progress against plan and escalate risks as appropriate.
Conduct proactive risk assessments related to start-up, enrollment, and site performance; define and execute mitigation plans to maintain study timelines.
Provide oversight of all site start-up activities, including contract and budget negotiations, CTA execution, investigator payments, and site activation readiness.
Partner closely with Contracts & Budgets, Legal, Regulatory, Clinical Supply, and other stakeholders to ensure alignment and timely delivery of start-up milestones.
Ensure start-up activities are conducted in compliance with ICH-GCP, regulatory requirements, and internal SOPs.
Lead the development and execution of patient recruitment and retention strategies in collaboration with internal teams and vendors.
Oversee the development, review, and approval of patient-facing recruitment and retention materials.
Monitor early enrollment trends and site engagement metrics, recommending adjustments to strategies as needed.
Participate in the selection, onboarding, and ongoing management of CROs and vendors supporting SSU activities.
Define, track, and evaluate vendor performance using KPIs and metrics; drive corrective actions and continuous improvement where needed.
Serve as a primary point of contact for SSU-related vendor deliverables and issue resolution.
Identify and implement industry best practices and innovative solutions to improve site engagement, start-up cycle times, and enrollment performance.
Contribute to the continuous improvement of SSU processes, tools, and metrics across the organization.
Stay current on industry trends, regulatory changes, and emerging technologies relevant to study start-up.