Clinical Study Manager

Description:

As a Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a CSL who has experience handling Third-Party Vendors. We need someone who can also give to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market.

Management of vendors and CROs

• 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

• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Lead (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 data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites

• Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work

• Ensure clinical project audit and inspection readiness through the study lifecycle

• Supports internal audit and external inspection activities and contributes to CAPAs as required

• Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability

• Contributes to clinical study report writing and review

• Facilitates and contributes to study level lessons learned

• Assigns tasks to Clinical Study Management staff and supports their deliverables

• Recommends and participates in cross-functional and departmental process improvement initiatives

• Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs

• Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

• May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring

Additional Skills & Qualifications:

Bachelors' degree with a minimum of 5+ years of relevant industry experience.

4+ years of Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents.

3+ years of experience managing vendors/CROs

You will also need technical proficiency trial management software and MS applications to be considered.

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.