Advanced Clinical

Posted: January 15, 2016

Job ID: 140

Job Summary

Term: Full-Time
Job Roles: Clinical Trial Monitoring
Therapeutic Experience: Oncology
Required Education: BS/BA in Life Science or related discipline
Required Experience: 4+ years
Compensation: Salary - Contract is possible as well

Job Description

Hope you are doing well. Please review the job opportunity below and contact me if you are interested or may know of someone interested.
Thank you in advance.

Advanced Clinical is a global, clinical outsourcing organization built around delivering a truly better clinical trial experience. We have a great job opportunity for a CTM/SR CTM to work within one of our leading pharmaceutical clients in South San Francisco, CA:
(Permanent, Contract, Consulting available for this role)

This individual will play a key role in assisting the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills.

Looking for candidates that are able to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals. Overall responsibilities may include the management of clinical operations activities and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve trial objectives and corporate goals.

Primary Responsibilities:

The Sr. Clinical Trial Manager (Sr. CTM) is accountable for planning and executing assigned global clinical trial(s) in accordance with the Clinical Development Plan (CDP). The Sr. CTM leads one or more cross-functional Clinical Sub Teams (CST) and will have overall responsibilities for managing the full scope of assigned clinical trials and coordinating the CST and vendor efforts in order to achieve study objectives and corporate goals. This position will report into the Clinical Program Manager (CPM) or Associate Director/Director (AD/D) of Clinical Operations.

Key accountabilities:
• Manage cross-functional team and vendor efforts to ensure clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
• Partner with CPM/AD/D to develop and implement operational strategy for assigned clinical trials including country selection, site selection, vendor selection, study timelines and budget.
• Partner with internal and external team members to ensure high quality cross functional deliverables, including investigator brochures, protocols, informed consent forms, case record forms clinical study reports, and study management plans.
• Partner with team members, vendors and sites to ensure the timely delivery of high quality clinical data.
• Identify and select CRO and clinical vendors. Onboard, provide direction, and oversee CROs and vendors to ensure delivery against scope of work. Track and manage to key performance indicators for vendors to ensure quality deliverables.
• Oversee implementation of study systems and including CTMS, TMF, EDC, IxRS, and sample management
• Proactively identify and mitigate study-specific risks. Effectively communicate study status, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders.
• Manage study budget. Partner closely with CPM/AD/D to ensure accurate accruing of study costs and forecasting of study budget. Review vendor invoices against contract and work completed; identify and transparently communicate variances. Oversee reconciliation of site payments against patient visits to ensure accurate payments.
• Partner with Contracts department on the development of site budget and CTA templates and negotiations with sites, until execution.
• Effectively delegate tasks and oversee deliverables of Clinical Operations team members assigned to studies.
• May assist with recruiting and hiring Clinical Operations staff.
• Mentor and coach junior staff
• Review and revise SOPs and working practices. Assist in the creation and improvement of department infrastructure to ensure that studies are conducted in compliance with applicable regulatory guidelines, as directed
• Participate in and may lead department process or system improvement initiatives.

• Proven ability to successfully plan, implement, and manage global clinical trials.
• Ability to manage cross functional clinical study teams to high performance
• Proven ability to effectively manage CROs and clinical study vendors
• Ability to negotiate with vendors and teams
• Strategic thinking skills
• Strong working knowledge of FDA & ICH/GCP regulations and guidelines
• Highly effective verbal and written communication and presentation skills in English
• Ability to travel internationally up to 25%
Education and Experience
• BS/BA in Life Science or related discipline
• 7+ years of experience in clinical and drug development
• Global clinical trial and CRO management experience in oncology

Please email me your resume/CV to mouranos@advancedclinical.com and let me know when you have time to discuss the position over the phone.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.
Thank you,

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439

Be Advanced. Advanced solutions for a better clinical experience.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.

Look up active jobs on our website & email me the job order # directly! http://www.advancedclinical.com/find-a-job