Lead Clinical Study Manager

Scorpion Therapeutics; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager to oversee clinical trial strategy and execution across development programs. This role ensures studies comply with ICH GCP and regulatory standards, stay on schedule, and meet budgets.

Responsibilities include trial planning, vendor management, protocol collaboration, site selection, budget control, and regulatory inspection readiness, with mentoring of junior staff and involvement in initiatives.

Qualifications

• 6+ years' experience in pharma or CRO with clinical study management experience.
• Exposure to early phase or Phase 2/3/global studies.
• Knowledge of global regulatory standards (US CFR, EU CTD, ICH GCP).
• Skills in project management, stakeholder communication, and team leadership.

Responsibilities

• Oversee clinical trial strategy and execution within development programs.
• Ensure studies meet quality standards, timelines, and budgets.
• Operational oversight of trials and vendor management.
• Collaborate on protocol development, feasibility, and site selection.
• Budget management and vendor negotiations; risk mitigation.
• Regulatory inspection readiness; mentor junior staff; participate in initiatives.

Education

BS/BA in life sciences or related field

Advanced degree(s) in related field

Job description

Role

Lead Clinical Study Manager responsible for overseeing clinical trial strategy and execution within Takeda's clinical development programs. Primary objectives include ensuring studies are conducted in compliance with quality standards (ICH GCP, regulations), on schedule, and within budget.

Responsibilities

• study planning,
• operational oversight of high-complexity trials (possibly multi-indication or involving DSMBs),
• vendor management,
• collaboration on protocol development, feasibility, and site selection.
• budget management,
• vendor negotiations,
• risk mitigation,
• regulatory inspection readiness.
• mentoring junior staff
• participating in functional initiatives.

Qualifications

• BS/BA in life sciences or related field;
• 6+ years' experience in pharma or CRO, including at least 4 years in clinical study management, with exposure to early phase or Phase 2/3/ global studies.
• Knowledge of global regulatory standards (US CFR, EU CTD, ICH GCP) required.
• Skills in project management, stakeholder communication, and team leadership essential.

Preferred

• advanced degrees, experience across multiple therapeutic areas, and international study oversight.

Location and Travel

The role is remote-based in Massachusetts with 5-20% travel, including international.

Focus Areas

Focus areas include clinical operations, vendor oversight, and compliance within a biologics or small molecule pipeline, supporting Takeda's patient-centric R&D efforts.