Easter Seals Jobs

Job Title: Clinical Trial Manager

Job Description

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas. Clinical Operations plays a key role in ensuring all clinical trials are performed in accordance with applicable SOPs, company policies, and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of products. You will work with and collaborate with Clinical Operations, Clinical Pharmacology, and other cross-functional team members. You will manage certain components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors, assist in the review of clinical study protocols and other study documents, contribute to process development, and participate in special projects and strategic initiatives.

Responsibilities

• Serve as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders for successful implementation of biomarker and bioanalytical strategies.

• Participate in multiple Phase 1-4 clinical study teams.

• Plan and coordinate all operational activities required with the collection, delivery, and analysis of biological specimens within a clinical trial.

• Provide sample management expertise to the Study Management Teams (SMTs), Biomarker Subteams (BSTs), and Clinical Pharmacology Subteams (CPST).

• Ensure biological samples collected are of good analyzable quality and adhere to the highest standards of ethics and informed consent.

• Act as the primary interface for operational activities between the SMT and laboratory vendors, providing day-to-day operational management of vendors.

• Critically evaluate scientific proposals or protocols and budgets for clinical operation feasibility.

• Establish strong cross-functional relationships and exhibit strong leadership skills with counterparts in other functional teams to ensure efficient execution of the study biomarker strategy.

• Identify potential operational challenges and collaborate with team members to provide resolution plans.

• Organize and lead Biomarker and Bioanalytical operational meetings with study functional groups or vendors.

• Maintain internal Biomarker and Bioanalytical Operations databases and document repositories.

• Review relevant documents including protocols, informed consents, and other study documents.

• Understand, interpret, and explain protocol requirements to others.

• Determine activities to support a project’s priorities within functional areas.

• Contribute to the development of RFPs and participate in the selection of CROs/vendors.

• Examine functional issues from an organizational perspective.

• Participate in special projects and develop tools and processes that optimize project efficiencies and effectiveness.

• Participate in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development.

Essential Skills

• PharmD / PhD with 2+ years' relevant clinical or related experience in life sciences.

• MA / MS with 3+ years' relevant clinical or related experience in life sciences.

• BA / BS with 5+ years' relevant clinical or related experience in life sciences.

• Advanced knowledge of study management best practices and tools.

• Thorough knowledge of FDA, EMA, ICH guidelines, and GCP governing the conduct of clinical studies.

• Familiarity with standard medical/scientific terminology.

• Experience managing the work of external vendors.

• Ability to communicate in a clear and concise manner.

• Ability to support a team-oriented, highly-matrixed environment.

• Ability to execute multiple tasks as assigned.

• Ability to travel when needed.

Additional Skills & Qualifications

• Demonstrated ability to be a fast learner.

• Demonstrated flexibility and adaptability to change.

• Ability to move between projects easily and provide support/expertise where needed.

• Ability to manage any component of full cycle study management, from start-up to close-out.

Work Environment

The work environment will be hybrid, with on-site presence required from Tuesday to Thursday.

Pay and Benefits

The pay range for this position is $66.67 - $86.27

• Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Foster City,CA.

Application Deadline

This position will be accepting applications until Dec 7, 2024.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.