Contract Senior Clinical Study Leader
Proclinical is currently recruiting for a Senior Clinical Study Lead with a leading biopharmaceutical company located in New York, NY. As the Senior Clinical Study Lead, you will be accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.
- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study.
- Provides operational input into protocol development.
- Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
- Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
- Ensures compliance with the clinical trial registry requirements.
- Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors.
- Provides input into baseline budget development and management.
- Provides input into baseline timeline development and management.
- Leads risk assessment and identifies risk mitigation strategies at the study level.
- Leads the feasibility assessment to select relevant regions and countries for the study.
- Oversees/conducts site evaluation and selection.
- Leads investigator meeting preparation and execution.
- Monitors progress for site activation and monitoring visits and acts on any deviations from plan * Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan.
- Monitors data entry and query resolution and acts on any deviations from agreed metrics.
- Ensures accurate budget management and scope changes for internal and external studies.
- Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Talent Acquisition Global Clinical Operations company Internal Use Only.
- Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues.
- Oversees the execution of the clinical study against planned timelines, deliverables and budget.
- Oversees and ensures the CROs and Third-Party Vendors are in alignment and are delivering per the scope of work.
Skills and Requirements:
- Bachelor's degree and minimum of 8 years relevant industry experience. Advanced degrees may be considered in lieu of relevant experience.
- Demonstrated interpersonal & leadership skills.
- Ability to understand and implement the strategic direction and guidance for respective clinical studies * A data driven approach to planning, executing, and problem solving.
- Effective communication skills via verbal, written and presentation abilities.
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization.
- Ability to influence and negotiate.
- Budget management experience Talent Acquisition Global Clinical Operations company Internal Use Only.
- An awareness of relevant industry trends.
- Ability to build productive teams and collaborations.
- Demonstrated vendor management experience.
- Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.
- Experience in global clinical trial operations including experience developing protocols and key study documents.
If you are having difficulty in applying or if you have any questions, please contact Matt Pike at email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.