Senior Clinical Trial Manager, Oncology (Home-Based) - Iqvia Biotech

Iqvia Holdings Inc Santa Fe , NM 87501

Posted 2 months ago

#IQVIA Biotech is actively seeking Clinical Trial Manager's with #Oncology experience (early phase solid and liquid tumor), #CART/Cell-Therapy experience preferred.

IQVIA Biotech delivers flexible, tailored, clinical and commercial solutions designed for biotech and biopharma companies. From planning, through trial design and delivery, and commercialization, IQVIA Biotech brings simplified operating procedures, specialized, therapeutically-aligned teams, and advanced data science to provide a more agile way for our customers to reach their drug development and commercialization milestones

POSITION TITLE: Senior Clinical Trial Manager

BASIC FUNCTIONS:

Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Responsible for all activities related to implementation and execution of clinical studies that include:

Client Duties/Responsibilities:

  • Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP.

  • Serve as client advocate within IQVIA Biotech.

  • Develop and implement Clinical Monitoring Plan.

Team Duties/Responsibilities:

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:

Coordinate site management activities:

  • Site identification, recruitment, and selection.

  • Regulatory document collection and review.

  • Overall scheduling and management of all site visits.

  • Develop site/monitoring tools and training materials.

  • Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.

Coordinate and oversee daily operations of clinical monitoring team:

  • Set and enforce project timelines with the assigned study team.

  • Coordinate remote review of clinical data within EDC system.

  • Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract.

  • Review and approve trip reports and follow-up letters within required timeframe.

  • Schedule and manage weekly CRA project team meetings.

  • Ensure CRAs assigned to team receive therapeutic and project-specific training.

  • Manage quality and regulatory compliance among clinical monitoring team and investigational sites.

Manage project milestones and proactively address deficiencies:

  • Attend and provide information at monthly projections meetings.

  • Attend and provide information at weekly client teleconferences/team meetings.

  • Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization.

Manage CRA performance:

  • Define and implement functional standards, goals, and expectations with clinical monitoring team.

  • Serve as CRA mentor and perform accompanied field assessment visits as required.

  • Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.

Documentation Duties/Responsibilities:

  • Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.

  • Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs.

  • Assist PM in preparation of audit responses, as appropriate.

  • Assist PM with preparation of information for inclusion in monthly report to client.

Budget/Contract Duties/Responsibilities:
  • Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

  • Define the scope of work with the client and clinical monitoring team.

  • Assist PM in identifying and generating changes in scope and notify client of potential changes in scope.

  • Review and approve CRA travel expenses and time sheets.

KNOWLEDGE, SKILLS & ABILITIES:

  • Thorough knowledge of clinical research process.

  • Strong communication skills (verbal and written) to express complex ideas.

  • Excellent organizational and interpersonal skills.

  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.

  • Ability to manage multiple priorities within various clinical trials.

  • Ability to reason independently and recommend specific solutions in clinical settings.

  • Understanding of basic data processing functions, including electronic data capture.

  • Working knowledge of current ICH GCP guidelines and applicable regulations.

  • Ability to work independently, prioritize and work with a matrix team environment is essential.

  • Working knowledge of Word and Excel.

  • Prior experience in electronic data capture (EDC) preferred.

  • Able to mentor CRAs and more junior Clinical Trial Managers.

  • Able to qualify for a major credit card.

  • Valid driver's license; ability to rent automobile.

  • Willingness and ability to travel domestically and internationally, as required.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Ability to travel domestically and internationally

  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies

  • Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis

  • Minimum of 2 years as a successful Lead CRA or Clinical Trial Manager.

  • Equivalent combination of education, training and experience

  • Oncology experience required (early phase solid and liquid tumor), CART/Cell-Therapy experience preferred.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

EU: N/A

#LI-Remote

#LI-AL3

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Operations Manager Trainee (Placing Nationwide/Relocation Required)

Biolife Plasma Services

Posted 1 week ago

VIEW JOBS 11/24/2020 12:00:00 AM 2021-02-22T00:00 * Growing Industry * Operations Manager Readiness Program * Competitive Pay & Benefits Serve a Greater Purpose * We Prepare You to Succeed * Professional & Friendly Culture * Senior Operations Management Trainee (Sr. OMT) Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 125+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: * Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. * Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. * Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. * Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. * Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. * Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: * 5 years of experience leading medium to large teams (20+ direct reports) * Up to 90-100% travel * Ability to walk and/or stand for the entire work shift * Willingness to travel and work at various BioLife locations across the country * Ability to work evenings, weekends, and holidays * Have a valid driver's license for the entire duration of the program * Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees * Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. * Fine motor coordination, depth perception, and ability to hear equipment from a distance * Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: * Associates or Bachelor degree * Experience working with SOPs, GDP, GMP, CLIA, and the FDA * Experience working in a highly regulated or high volume retail environment * Excellent interpersonal, organizational, technical, and leadership skills We Offer Comprehensive Benefits from Day One * Major medical, dental and vision insurance and prescription coverage for eligible employees * A minimum of 15 vacation days and 10 company paid holidays * Tuition reimbursement * Retirement savings with a generous employer contribution and matching program * Short and Long-term Disability Insurance * Life and AD&D insurance About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Notice to Employment / Recruitment Agents: Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda's Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Equal Employment Opportunity Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf EEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf Reasonable Accommodations Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information. Biolife Plasma Services Santa Fe NM

Senior Clinical Trial Manager, Oncology (Home-Based) - Iqvia Biotech

Iqvia Holdings Inc