Local Study Associate Director (FSP )

Parexel - King of Prussia, PA

Full-time - Mid Level

King of Prussia, PA

Professional, Scientific, and Technical Services

About the position

The Local Study Associate Director (FSP) at Parexel International Corporation is responsible for overseeing the commitments of clinical studies within the country, ensuring timely delivery of high-quality data. This role involves leading the Local Study Team, which includes Clinical Research Associates (CRAs) and Clinical Study Associates (CSAs), to optimize their performance while ensuring compliance with CLIENT Procedural Documents, ICH-GCP, and local regulations. The Associate Director will coordinate the site selection process, conducting feasibility assessments, and ensuring that all necessary documentation is submitted to Ethics Committees (EC) and Institutional Review Boards (IRB) in a timely manner. In addition to managing the study commitments, the Associate Director will prepare and maintain the financial Study Management Agreement (fSMA) and oversee the budget for clinical studies. They will also be responsible for preparing the Master Informed Consent Form (MICF) and ensuring that all essential trial documents are collected and verified before the study begins. The role requires planning and coordinating local drug activities, maintaining the study in the Clinical Trial Management System (CTMS), and managing monitoring activities from site activation to study closure. The Associate Director will proactively identify risks and resolve complex study issues, organize regular meetings with the Local Study Team, and maintain good relationships with team members, site staff, and global stakeholders. They will report study progress to the Global Study Associate Director and contribute to patient recruitment strategies. The role also involves developing and reviewing risk management plans, ensuring compliance with local policies and ethical standards, and participating in training new team members. Overall, this position plays a critical role in ensuring that clinical trials are conducted efficiently and in compliance with all regulatory requirements.

Responsibilities

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
• Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with CLIENT Procedural Documents, ICH-GCP and local regulations.
• Ensures clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in CLIENT clinical studies financial system.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports and pro-actively advises the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organizes regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites' staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan on country study level.
• Communicates and coordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures relevant systems required to facilitate business critical activities are set-up, updated and access is organized at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and CLIENT Procedural Documents.
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF 'Inspection Ready'.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with Client's Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Requirements

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Development Operations (CRA, SCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent attention to details.
• Excellent knowledge of spoken and written English.
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.

Nice-to-haves

• Good medical knowledge and ability to learn relevant CLIENT Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• Very good understanding of the Study Drug Handling Process and the Data Management Process.
• Integrity and high ethical standards.
• Good analytical skills.
• Good resource management skills.
• Good decision making and delegation skills.
• Good financial management skills.
• Basic change management skills.
• Basic coaching skills.
• Basic ability in handling crisis situations.
• Good intercultural awareness.

Benefits

• Health insurance coverage
• 401k benefit for retirement savings plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities