Clinical Study Team Associate II (CSTA II)

Overview

As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.

In return, Parexel offers a supportive work environment, and a high degree of empowerment and accountability to lead your studies. Within this role, you work with a diverse set of clients and therapeutic areas, and you are encouraged to take on new challenges and pursue your interests.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Adaptable
• Communicator
• Collaborative
• Leadership
• Proactive
• Problem-solver

About This Role

Parexel FSP is looking for CSTA II to join our FSP team! Candidates can be based in Argentina, Brazil and Mexico.

Job Overview

The Clinical Study Team Associate II (CSTA II) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating Procedures (SOPs). The role collaborates with global study team members and is responsible for multiple tasks that span from study start up to study close out which enables the efficient execution of clinical trials to high quality standards.

Key Accountabilities (may include but not limited to the following):

• Operations:

• Responsible for providing study level operational support to the study team from study start up to close out and submission

• Maintains and oversees of study team shared spaces

• Trial Master File (TMF) maintenance, compliance, and oversight

• Analyze, interpret, and follow up on metrics

• Maintains and oversees Study Team on Demand (STOD)

• Analyzes, interprets, and follows up on metrics

• Maintains client registries and systems as required to ensure compliance

• Tracks and oversees study information; follows up with functional lines as needed

• Liaises with cross functional study team members:

• Initiates and coordinates the completion of study level forms and data entry into various clinical operations applications and systems

• Provides study level reporting to support management of clinical trial data, clinical trial budget and timelines

• Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission

• Supports engagement of Independent Oversight Committees

• Provides support with audit and inspection readiness activities

• Assists with oversight and tracking of clinical trial budget spend

• Provides logistical and operational support for Investigator Meetings

• Coordinates the translation of documents as required

• Provides status updates on key tasks and contributes to study team meetings

• Provides support to study teams with system setup and maintenance

• May provide support for global study team communications to sites

• Works proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes

• Ensures the completion of assigned tasks according to timelines and to required quality standards

Collaboration

• Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams

• Partners with the Global Study Manager and the Study Manager in providing site management, monitoring and vendor operational oversight and support

• Collaborates with global cross functional study team members of varying levels of seniority

• Clinical Study Team Lead

• Global Study Manager

• Study Manager

• Start Up Project Manager

• TMF Study Owner

• Clinician, Process & Standards Lead

• Clinical Quality Lead

Subject Matter Expert (SME)

• Provide support to CSTA managers for development and implementation of onboarding training for new hires and provide training to new hires

• Mentor new hires and entry level CSTAs

• Serve as Subject Matter Expert (SME) for key CSTA processes, systems and tasks

• Work with CSTA managers to identify continuous improvement opportunities to enhance operational efficiencies

Compliance with Parexel standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

Skills

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)

• Effective verbal and written communication skills

• Fluency in written and spoken English required

• Ability to work independently but also as part of a larger team

• Ability to multitask and manage multiple competing priorities

• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

• Good problem solving and decision-making skills:

• Seeks input from others when faced with a difficult situation

• Makes sound decisions within the scope of responsibility

• Focuses on resolving problems

Knowledge and Experience (preferred):

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research

• See below Education section for minimum requirements

• Science background

• Experienced with clinical trial processes and applicable systems

• Knowledge of drug development process

• Requires fundamental knowledge of the principles of the role and applies these skills to achieve assigned tasks

Education

• Bachelor’s of Art or Bachelor’s of Science with minimum of 3 years experience or

• Master’s of Art, Master’s of Business Administration or Master’s of Science with minimum of 1 year experience

• LI-REMOTE

• Potential Career Path

• Parexel offers a growth path with diverse therapeutic areas and clients, so you can grow according to your interests.

• Associate Project Leader

• Project Leader

• Senior Project Leader

• Associate Project Director

• Project Director

• Director, Project Leadership

• Senior Director, Project Leadership

• Employee Insights

• Donata about the team culture and career growth

• Donata Juske | Senior Project Leader

• Watch Video

• Helen on the diverse work experience

• Helen Buttinger | Associate Project Director

• Watch Video

• Briar on creating work-life balance

• Briar Jallad | Associate Director, Project Management

• Watch Video

• Why Project Leaders work at Parexel

• Patient-led in everything we do

• We lead and drive the success of clinical trials and feel the satisfaction of seeing the positive impact of our work on patients' lives.

• Supportive and inclusive environment

• We build a culture where relationship building is a priority for the success of our cross-functional teams and our client interaction.

• Accountability and growth

• We provide Project Leaders with the responsibility and empowerment to turn challenges into achievements and development opportunities.

• Flexible work arrangements

• We offer remote, in-office and hybrid roles to balance work and personal life depending on your needs.

• Varied project experience

• We continuously learn from a broad exposure of small biotech or large pharma clients, different therapeutic areas and innovative trial design.

• Career progression

• We offer various career paths, including enhancing your position, moving into management, or developing into other areas of the business.

• Learn About Our Culture

• Careers in Neuroscience

• Neuroscience diseases affect the very core of one’s being and experience. We work diligently to lighten the burden for patients and families alike. Explore opportunities to join our team.

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• Careers in Cell and Gene

• Cell and gene therapies (CAGT) have rapidly emerged as among the fastest-growing spaces in all of biopharma R&D, and Parexel was an early entrant into this space.

• Learn More

• Our work culture

• Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work culture prioritizes patient care and employee growth.

• Learn More

• Careers in Oncology

• Our dedicated people, innovative approaches, and culture of caring all work together to ease the journey for patients and investigators.

• Learn More

• Careers in Rare Diseases

• In rare disease, every single patient is precious. Discover where your skills can create a life-changing achievement for every person involved.

• Learn More

• Emerging Talent Opportunities

• Begin your career journey at Parexel with our emerging t