ExecuPharm FSP - Senior Study Manager

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Position Purpose:

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

Organizational Relationships:

• Reports to ExecuPharm (EP) 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 EP, as necessary, including general training

requirements, SOPs, and system and process related training

• Adhere to EP and Client SOPs and processesQualificationsSkills 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 beneficialEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.