Clinical Scientist

Parexel – Clinical Scientist

Primary Location: United States, Remote

Job ID R0000046411 Category Medical Affairs

About this Role

Parexel FSP has exciting opportunity for a Clinical Scientist! The Early Clinical Scientist (ECS) may lead or support an early phase clinical study or studies, depending on size/complexity. The ECS is accountable for the clinical/scientific execution of the protocol.

Key Accountabilities:

Oversight/Leadership

• Responsible for coordinating the design, planning and execution of early phase clinical trials in collaboration with the Clinical Director, and internal/external team members
• Oversees trials within and/or across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity
• Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.)
• Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise
• Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues

Clinical Trial Operational Delivery

• Monitors clinical safety assessment and risk management of compounds
• Provides risk assessment and contingency planning, under accelerated timelines
• Reviews and interprets clinical trial data
• May conduct on-site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes
• Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports and ensures documents are completed in accordance with applicable standards
• Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.)
• May be required to review budgets and approve invoices for payments to vendors.

Compliance with Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills

• MS Office Suite Experience Required– including Word, Excel, Power Point, and Teams
• Strong team collaboration, leadership, communication (written and verbal), issue identification and resolution skills
• Proficient in written and spoken English
• Proficient in local language (as applicable)
• Ability to manage multiple projects and varied tasks and prioritize workload with attention to detail
• Ability to manage complex operations and projects under accelerated timelines
• Ability to partner effectively with internal and external teams to achieve results
• Ability to quickly develop a working scientific knowledge of different therapeutic areas
• Ability to build knowledge and skills to effectively manage additional processes/procedures
• Ability to build knowledge and skills to effectively manage additional processes/procedures

Knowledge and Experience:

• Experience in managing CROs from the Sponsor side for Phase 1 clinical trials
• Use of Clinical Trial Management and Trial Master File systems
• Authoring Protocol Concepts
• Facilitating a Trial Team including cross functional partners such as regulatory, clinical supplies managers, data managers, statisticians, programmers, procurement, etc.
• Reviewing the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
• Understanding of clinical research development process from program planning to regulatory submission
• Scientific, medical and/or safety writing and reporting (at least one is required)
• Knowledge of GCP, ICH guidelines and regulatory requirements
• Familiarity with early drug development processes

Education

• Degree in Life Sciences

• Bachelor’s degree and ≥7 years related experience OR

• Master’s degree and ≥5 years related experience OR

• PhD or doctorate degree and ≥1 year related experience

• 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.

• Cell and Gene

• Our Cell and Gene Therapy Center of Excellence (COE) integrates regulatory expertise with a cross-functional team to get treatments to market faster.

• Learn more

• General Medicine

• Our general medicine thought leaders provide innovative development strategies and principled trial design and conduct across the following indications: Cardiovascular, Endocrinology and metabolism, Nephrology and genito-urinary, Respiratory, and Women’s health.

• Learn more

• Hematology

• Our specialists in hematology have long been at the cutting edge of innovations, treating patients participating in clinical trials from first-in-human to post-market studies across the indications of Lymphoma, Acute myeloid leukemia (AML), Myelodysplastic syndrome (MDS), Multiple myeloma, Benign and malignant disorders.

• Learn more

• Infectious Disease and Vaccines

• Our infectious disease team is built upon the global experience and public health knowledge that drives research within these indications: Hepatitis B, Bacterial indications, Vaccines, preventative, and treatment, Critical care, Long COVID syndrome.

• Learn more

• Inflammation and Immunology

• Our broad knowledge of the underlying mechanisms of diseases, paired with medical expertise and global operations, enable us to support demands in Allergy/immunology, Dermatology, Gastroenterology, Ophthalmology, and Rheumatology.

• Learn more

• Neuroscience

• Enormous advances in the understanding of how the brain works and development of treatment modalities are cause for great hope for millions of people affected by neurological disorders. Our expertise covers all indications across neurology and psychiatry.

• Learn more

• Oncology

• We support treating all major types of cancer, across every phase of development, and the following indications: Benign and malignant hematology, Breast and gynecological cancers, Gastrointestinal cancers, Genitourinary cancers, Lung and head-and-neck cancer, Phase I and rare tumors.

• Learn more

• Pediatrics

• Our dedicated team of pediatric experts brings a patient- and family-centered approach to protocol development and study conduct to improve participation, accommodate patients’ needs, and successfully support trials from start to finish.

• Learn more

• Rare Diseases

• Our best-in-class team of rare disease experts are ready to tackle even the most complex trials with their clinical and regulatory expertise, while seamlessly aligning a study with the journey of the patient and caregiver.

• Learn more

• Parexel Academy

• Whether you are getting started in the biopharmaceutical industry, a seasoned vet looking to keep growing your career, or somewhere in between, the Parexel Academy can support your professional development through our diverse array of learning solutions.

• Learn more

• Career Development at Parexel

• Discover how Parexel supports your professional growth through manager support, skill development, career planning, and AI training. Learn about our commitment to your success in clinical research.

• Learn more

• 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.

• Learn more

• 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 talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind.

• Learn more

• Parexel’s hiring process

• It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be succ