Senior Study Manager

Parexel FSP is looking for Senior Study Manager!

Job Title: Senior Study Manager (SSM)

Position Purpose: The SSM may lead or support a study or studies, depending on the size/complexity.

Organizational Relationships:

• Reports to Parexel FSP assigned Line Manager with day-to-day direction from the Client

 • Liaises with cross-functional lines as appropriate

 Primary Duties:

• Operational point of contact for trial execution and all trial deliverables

• Manages all Headquarters (HQ) Operational Activities, including: establishes, leads and manages Clinical Trial Team (CTT), supports clinical (drug/vaccine) supplies planning

• Manages deployment and interactions with external vendors [e.g. Interactive Voice Response System (IVRS), Patient Reported Outcomes (PRO)]

• Initiates planning for Investigator meetings and protocol training

• Plans and assesses protocol ancillary supplies

 • Completes trial set-up and maintains SPECTRUM

• Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT

• Initiates recruitment/retention planning & enrollment tracking

• Responsible for tracking study related details (e.g., specimens, queries)

• Oversees protocol training activities including Investigator Meetings (IM) and Clinical Research Associate (CRA) training meetings

• Ensures appropriate postings to investigative site portals

• Responsible for operational deliverables in preparation for site ready, country allocation, and achievement of recruitment targets (with input from others)

• Point of escalation for study related operational issues

• Responsible for operational details at Operational Reviews

• Responsible for creating and maintaining project schedule and collaborating with Program Lead

 • Sets up and maintains Trial Master File (eTMF)

• Ensures alignment of budget with protocol needs

• Responsible for executing protocol within the budget

 • Responsible for risk assessment, mitigation planning and execution

• Responsible for creating and maintaining Actions, Decisions, Issues (ADI) Logs

• Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group

• Develops study related manuals (e.g., administrative binder, lab manuals)

 • Manages Emergency Unblinding (EUB) Call Center activities

• Co-authors newsletters with Clinical Scientist (CS)

• Approves contracts, invoice payments and change orders for vendors, as necessary

 • Responsible for end of study reconciliation (clinical and ancillary supplies)

• Oversees all HQ close-out tasks

• Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking

• Supports CS activities as needed to achieve CTT deliverables

• Interface with External Data Coordination and Data Management

• Responsible for quality control and inspection readiness at all times

• Complete training assigned by Client and/or Parexel as necessary, including general training requirements, SOPs, and system and process related training

• Adhere to Parexel and Client SOPs and processes

Skills and Education:

• BS/BA/MS/PhD with 7+ years clinical research experience

• Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead Study Manager (SM) required.

 • Proven ability to meet aggressive timelines

• Excellent Excel and PowerPoint skills required

• Excellent oral (including presentation) and written communication, computer/database management, and project management skills required

• MS Project experience preferred

 • Therapeutic Area (TA) specific experience beneficial

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.