What are the responsibilities and job description for the Clinical Study Lead position at Actalent?
Description:
Global Trial oversight of 2 studies within Early Clinical Development. Responsible for leading global clinical trials from start up through closure (internally sourced studies and studies outsourced to CROs). Direct Management and oversight of third-party vendors and CROs. Experience driving process improvement initiatives. Will be responsible for developing study specific documentation (Case report forms - CRFs, data management plans, monitoring plans, monitoring oversight plans, data review plan, statistical analysis plan, etc. Responsible for leading risk assessments and identifying risk mitigation strategies at the study level. Directly supervising Clinical Trial Management staff, including assigning work, performance management, recruitment, mentoring and professional development
Managing Phase I - IIb global clinical trials (start up through closure)
Management of vendors and CROs
CTMS & TMF System - Veeva Vault - supervising setup and maintenance of study teams
Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results
Start Up:
Managing feasibility assessment to select relevant regions and countries for the study
Conducting site evaluation and selection
Leading investigator meeting preparation and execution
Monitoring progress for site activation and monitoring visits and acts on any deviations from plan
Managing development and implementation of patient recruitment and patient retention strategies
Maintenance:
Monitoring data entry and query resolution and taking action on any divergence from agreed metrics
Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required
Close out:
Supervising study close-out activities and contributing to clinical study report writing and review
Skills:
Vendor Management, Clinical Research, Clinical Trial, global, Clinical Study, Clinical Operation, clinical trial management
Additional Skills & Qualifications:
Bachelors Degree
5 years of experience LEADING GLOBAL Clinical trials within Pharma Industry
2 years of experience within Early Development (Phase I-IIb) - leading studies
5 years of experience managing and overseeing CRO's and vendors
Chronic Kidney Disease (CKD), Cardio, or Imaging Experience
Looking for someone who shows a lot of drive and energy and can handle large workload, attention to detail very important
Experience Level:
Expert Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $75 - $95
