Aptask Global Workforce (AGW) is seeking a Manager, Study Management for a Remote position with a Major Pharmaceutical Company. This is a 12+ month contract opportunity. This role serves as the primary point of contact to lead, manage, and coordinate the conduct of clinical trials from study design to close-out at a global level. The ideal candidate will partner with a Contract Research Organization (CRO) to oversee the quality and scientific integrity of clinical operations for biosimilar studies, ensuring execution is on time, within budget, and in accordance with ICH-Google Cloud Platform guidelines.
Responsibilities: - Oversee global biosimilar development operational execution through oversight of cross-functional trial activities in partnership with the CRO
- Ensure implementation of trials in accordance with applicable SOPs and ICH/Google Cloud Platform guidelines
- Contribute to the authoring and review of key study documents such as synopses, protocols, study plans, and Clinical Study Reports (CSR)
- Manage day-to-day study execution, including management of study timelines and program-level operational issues
- Lead or support the execution of all studies for a biosimilar program, including PK/PD studies, global pivotal studies, and chart reviews
- Oversee the development of study timelines and budgets
- Support global recruitment forecasting, global enrollment, and any recruitment enhancement initiatives
- Contribute to inspection readiness activities, including TMF review
- Communicate the global status of clinical study programs to senior management
Requirements: - Bachelor's degree & 5 years of directly related experience OR Master's degree & 3 years of directly related experience OR Doctorate degree & 2 years of directly related experience
- Experience with oversight of clinical research organizations (CROs)
- Experience in leading cross-functional teams
- Experience working for a Sponsor (pharmaceutical/biotech company) and for Contract Research Organizations (CROs)
- Ability to assume ownership of tasks with limited guidance
- Broad knowledge of Good Clinical Practices (Google Cloud Platform), FDA regulations and guidelines, and international regulatory requirements/guidelines
- Proven ability to anticipate and resolve problems
Desired skills: - 7-9 years of work experience in life sciences or a medically related field, including biopharmaceutical clinical research experience
- Experience in oversight of outside vendors (CROs, central labs, etc)
- Experience in Informed Consent Form (ICF) review, sample management/tracking, and eTMF (Trial Master File)
- Experience with data listing/patient profile review and working with data management
- Excellent oral and written communication skills
- Experience working in a global, matrix organization on global clinical development programs
- Solid understanding of Biopharmaceutical/Healthcare Compliance
Pay range: up to $71.42 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
