Description:

Clinical Study Specialist supports Clinical Study Leads on overall execution of global clinical trials (both internally sourced studies and studies outsourced to CROs).

Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings

Collates data for assessments such as feasibility and site selection and reviews site usability database

Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures

Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders

Trial Master File reconciliations; manages and maintains the eTMF, ensures scheduled reports are received (1572, re-portable changes, financial disclosures), Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits

Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan

Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings

Contributes to line listings review for Blind Data Review Meeting (BDRM)

May manage or contribute to oversight of Third Party Vendors (TPV)

Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives

Additional Skills & Qualifications:

site level is ok with 4 years

2 years of clinical trials experience (Pharma experience preferred)

2 years of managing Trial Master File

2 Experience supporting CTMs on CRO management

2 years of Taking Meeting Minutes

Bachelors Degree minimum

Experience Level:

Entry 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.