Clinical Study Associate Manager

Leading mid size physician - scientist led biotech is looking to hire a Clinical Study Associate Manager to their team!

Description:

The Clinical Study Associate Manager role supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct execution versus oversight of CROs deliverables will vary accordingly. The Clinical Study Associate Manager works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies.

The Clinical Study Associate Manager will be assigned activities by the CSL, including:

• May lead/oversee the planning and management of a Clinical Study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study

• Contributes to risk assessment and helps identify risk mitigation strategies

• Supports feasibility assessment to select relevant regions and countries

• Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.

• Reviews site level informed consents and other patient-facing study start-up materials

• Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution

• Oversees engagement, contracting and management of required vendors for the study

• Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation

• Provides regular status reports to stakeholders as requested by the Clinical Study Lead

• Contributes to development of and oversees implementation of recruitment and retention strategies

• Monitors recruitment and retention

• Monitors progress for site activation and monitoring visits

• Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites

• Escalates data flow and data quality issues to Clinical Study Lead

• Oversees the execution of the specific Clinical Study deliverables against planned timelines

• Escalates issues related to timelines or budget to Clinical Study Lead

• Supports accurate budget management and scope changes

• Contributes to clinical project audit and inspection readiness throughout the study lifecycle

Additional Skills & Qualifications:

• Bachelor’s degree and a minimum of 5 years industry related work experience.
• Excellent communication and interpersonal skills; ability to build relationships internally and externally
• Attention to details for the ability to deliver on specific study activities
• Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.