Clinical Trials Management Associate - III*
American Cybersystems, Inc.

Job Info

Innova Solutions is immediately hiring a Sr. Clinical Trial Management Associate (Senior CTMA)

Position type: Full-time Contract
Duration: 6 months and possibility for extension
Location: Foster City CA

As a Sr. Clinical Trial Management Associate (Senior CTMA), you will:

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 support other Clinical Operations team members in the start-up, maintenance, and close-out of clinical studies. You may manage certain components of clinical studies and act as a member of the study team. You may also manage vendors and/or manage investigator-sponsored research. You may assist in the review of clinical study protocols and other study documents, contribute to SOP development and/or participate in special projects.
EXAMPLE RESPONSIBILITIES:
• Leads or manage components of Phase I, II or III studies
• Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors.
• May assist as operational contact for studies
• Plans and coordinates all operational activities required with the collection, delivery and analysis of biological samples within a clinical trial
• Manages study timelines, including documentation and communications
• Serves as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategy in (GS) and Collaborative (CO) programs
• Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
• Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.
• Participates in the review and approval of main study and optional informed consents, and may review additional study specific informed consents
• Contributes to SOP development and/or participates in special projects
• Develops tools and processes that optimize project efficiencies and effectiveness.
• Proactively identifies potential operational challenges and collaborates with key stakeholders to provide solutions to ensure study execution remains on track to projected budgets and timelines.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
• MA/ MS / PharmD / PhD with 2 + years relevant clinical or related experience in life sciences.
• BA / BS / RN with 4 +years relevant clinical or related experience in life sciences.
• Experience in managing the work of external vendors.
• Meets all requirements for Clinical Trial Management Associate (CTMA) grade 25 position with demonstrable proficiency.
Knowledge & Other Requirements
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Knowledge of full cycle clinical study management, from start-up to close-out, and has shown ability to effectively apply this knowledge to achieve targeted study outcomes.
• Significant industry knowledge.
• Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Familiar with standard medical / scientific terminology.
• 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.
• When needed, ability to travel.

Top 3 Required Skill Sets: sample management experience, strong Microsoft skills, excellent communication skills

Top 3 Nice to Have Skill Sets: clinical operations/bioanalytical operations experience, laboratory (bench) experience
*APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Thank you!

Vishnu Kaushik
Email: vishnu.kaushik@innovasolutions.com
Phone - 678-207-5230

PAY RANGE AND BENEFITS:
Pay Range*: $58- $60 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.