About Integrium » Careers
Integrium is a progressive employer offering competitive benefits and growth opportunities
tailored to each employee’s skills and qualifications. We understand our service
to our clients is only as strong as our service to each other, so we strive to create
an atmosphere that fosters the achievement of professional and personal goals.
At Integrium, we combine cutting-edge science and practical operational management
to provide high-quality clinical trial services to our biopharmaceutical clients.
We provide highly ethical and honest service with approachable, accountable, capable
and committed professionals. Are you one of those professionals? If so, we want
to hear from you.
We are currently seeking qualified candidates for the following open positions:
If you are interested in any of the opportunities listed above, please submit your resume/CV to:
Integrium Human Resources Department 14351 Myford Road Tustin, CA 92780
Fax: (714) 210-7086
Email: Regina.Ottaviano@integrium.com
Associate Director, Business Development - Southern CA
Integrium, LLC is seeking a likeable, high energy, positively optimistic, driven, dynamic, focused, tenacious,
highly accountable, and organized junior business development champion. Has a mind set of, “I want to learn something new every day”.
The ideal candidate has a willingness to expand current skills sets and knows how to develop deep personal relationships.
Likes to brainstorm, solve problems and knows a great opportunity when he or she sees it.
Candidate is comfortable in social settings and is competitive by nature. He or she asks a lot of questions and applies the answers.
Candidate Is excited about building a book of new business.
Job Description / Tasks:
The Associate Director, Business Development is responsible for securing new business from pharmaceutical, biotech,
and device companies within Integrium’s target market in the assigned territory.
They will have ownership within their territory of the process of leads identification and prospecting,
and generating interest in Integrium’s capabilities.
High daily cold call / warm call average/ High daily email average.
Will belong to a targeted networking group. Is creative in finding ways to get in the door.
Will locate and attend local Biotechnology and Pharmaceutical conferences / events.
This will include actively seeking and helping to conduct meetings and presentations with potential clients.
The Associate Director BD will have a supporting role in responding to requests for proposals and proposal defense meetings,
and will coordinate closely with Integrium’s operations and contracts teams in this process.
They will also work closely with assigned current clients in securing repeat business.
The Associate Director BD will have a key role in promoting Integrium’s name within the industry - both in developing
and executing strategies in support of this effort.
Reports to the Executive Director of Business Development.
Education:
College Degree
Some understanding of the clinical trial space
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Associate Director of Quality Systems (QS)
The Associate Director of Quality Systems responsibilities include auditing clinical sites and vendor locations,
coordinating , participating in and managing sponsor audits, ensuring that Integrium process
and system meets all aspects of Good Clinical Practice, ICH Guidelines and FDA regulations.
The Associate Director of QS will be the primary contact with regulatory authority inspections.
He or She will develop training curriculum for all direct reports.
Other responsibilities include managing Integrium’s internal compliance program
and provide trend analysis to Senior Management regarding SOP compliance and audit risk analysis.
Required Background:
- Minimum of Bachelors Degree in a health science field or equivalent industry experience.
- Minimum five (5) years of industry experience, with up to one (1) year supervisory experience.
- Experience in developing, maintaining, and writing Standard Operating Procedures.
- Experience in conducting clinical site audits, vendor audits, and internal compliance audits.
- Computer proficient in a Microsoft Windows environment, with a focus on Word, Excel, Access, Outlook and Internet Explorer.
- Experience working independently in a detailed fashion, prioritizing multiple tasks demonstrating strong initiative.
- Polished interpersonal, written and oral communication skills with personnel at all levels.
- Experience interpreting the requirements of a study protocol, and conveying the details accurately to site personnel.
- Travel up to 5%
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Sr. Regional Clinical Project Leader (Clinical Project Manager)
The Sr. Project Leader (PL) provides customer-focused leadership in managing multiple Phase I
through Phase IV clinical research trials across functional areas.
This position is accountable for the successful completion of all assigned global studies and/or projects,
where success includes all of the following: on-time, on-budget, in compliance with all applicable regulations,
quality data and reports, satisfied customers.
This position is also accountable for proposal development and bid defense for assigned RFPs
and functions as an integral part of the selling team and is administratively responsible for assigned clinical staff.
Duties:
- Manage and direct several full-service, multi-national and domestic projects, from proposal development to final deliverables to the customer.
- Provide senior oversight for designated programs and may be responsible for specific client account.
- Report to Management on the global aspect of the designated project.
- Prepare and present study material at client meetings and communicate outcome to project team.
- Evaluate and manage project budget against project milestones to ensure maximum project profitability.
- Take corrective measures where necessary to keep project in line with budget and profit expectations.
- Assess scope of work against contractual agreements and identify change in scope when appropriate, responsible for preparation of CIS and presentation to customer.
- Serve as a mentor for Project Leader development.
- Will often serve as the assigned Program Leader for “complicated” domestic trials, including those in complex therapeutic areas and those with new customer relationships.
- Responsible for site recruitment and selection. Identifies potential sites for participation in a clinical trial.
- Leads team in development and implementation of actions to ensure adherence to study timelines, deliverables and obstacles.
- Conduct all internal and external Study Project team meetings.
- Manage the preparation of agendas and records minutes for project meetings per scope done by the PL or CSC.
Education and Experience Required:
- BS/BA, RN, or equivalent; graduate degree preferred but not required.
- 5 or more years of qualified project management experience in a clinical research environment.
- Demonstrated experience in all three areas of competency;
- Proven track record for the management of complex budgets and time lines,
- business development experience including proposal generation and bid defense with numerous successes resulting in significant business wins,
- negotiation and financial accounting
- Knowledge of FDA regulatory requirements/guidelines (i.e. CRFs, ICH, GCPs, etc.) is mandatory.
- Demonstrated knowledge and a clear understanding of the overall drug development process, including experience with most phases of the clinical research process.
- Previous technical and managerial experience in conducting multi-national and/or local clinical trials in a pharmaceutical company or CRO is preferred, but not required.
- Excellent verbal and written communication skills, along with excellent organizational, record retention, time management, customer service, and interpersonal skills.
- Exceptional organizational and time management skills and ability to multi-task projects for timely completion.
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Sr. Regional CRA - Southern California, Colorado, Florida, Ohio
- Ensure that the rights, well-being and safety of human subjects are protected.
- Perform and coordinate all aspects of the clinical monitoring process in compliance with ICH/GCP guidelines and other regulatory agency guidelines.
- Conduct site visits to determine protocol and regulatory compliance and prepare required documentation.
- Ensure that the data reported in site source documents is accurate, complete and verifiable.
- Maintain ongoing and continuous professional communication with the clinical site and the study team throughout the duration of the study.
- Mentor junior level CRAs and serve as a resource for newly hired CRAs.
- Assist with site selection as directed by team members.
Education and Experience Required:
- Bachelor’s degree in health science or related field.
- Minimum of 5 years of CRA experience in the CRO/Pharmaceutical industry.
- Available to travel a minimum of 70% of the time, or as requested.
- Excellent problem-solving skills.
- Strong attention to detail and accuracy.
- Strong commitment to quality.
- Must be customer oriented and flexible.
- Must be able to work independently and in a team environment, and working well with others in high-pressure situations.
- Excellent ability to communicate effectively and clearly, both orally and in writing.
- Exceptional organizational and time management skills and ability to multi-task projects for timely completion.
- Must have ability to utilize a credit card for hotel, rental car and related expenses while traveling.
- The ability to utilize this card for those expenses must be for at least one month to cover required site visits within that month.
- Must have a reliable form of transportation (not provided by Integrium).
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