Senior Manager, Clinical Operations

Urgent requirement for one of our top clients located in “Palo Alto, CA”

Please contact me at your earliest convenience, along with job No.C0m_050908 as a Subject to: srikanth.kadakanc@makrotech.com

Job Title : Senior Manager, Clinical Operations
Responsibilities:

•Act independently and with limited supervision to guide/supervise the process of clinical trial planning, execution, and close-out

•Represent the clinical operations function on Project Teams and /or Clinical Sub-Teams as directed, and translate and communicate strategic and corporate goals to internal and external vendors and sites.

•Translate clinical trial concepts/outlines as generated by clinical research into final study designs and protocols which ensure reliability of data collection and which maximize efficient trial execution

•Make timely and sound trial execution decisions based on technical clinical operations expertise and experience. Prioritize the assignments of internal and external teams

•Interact with other functional managers across multiple functional areas to facilitate smooth work processes and communication

•Develop and facilitate internal buy-in to clinical protocols, monitoring plans, and vendor contracts/scopes to ensure that all vendor deliverables are well-defined, and that trials are executed in accordance with corporate goals.

•Oversee the vendor selection process, and guide vendor management in order to ensure adherence to work scope and budget

•Chair and/or supervise leadership of Study Specific Work Team(s) in order to ensure the clinical operations deliverables of the SSWT.

•Supervise tracking/management of trial progress in order to ensure that trials are completed per protocol, in accordance with company/project goals, and in accordance with ICH GCP, 21 CFR, and other applicable laws/regulations

•Manage clinical operations program budgets to ensure that trials are budgeted appropriately, and that internal/external operating costs are closely managed – work directly with finance to generate accurate monthly/quarterly accruals for all external vendors

•Manage team of trial-specific direct and indirect reports in order to pro-actively anticipate issues in trial design, execution, enrollment, and close-out. Oversee the resolution of trial-specific issues via SSWTs, and communicate concerns to senior management as appropriate

•Contribute toward the creation, development, and implementation of department-wide initiatives including SOPs, and functional improvement initiatives

•Provide technical clinical operations expertise, leadership and guidance to more junior clinical operations staff, and to external vendors as necessary.

Qualifications:

•Bachelor’s degree in a scientific discipline, with 7+ years of industry-sponsored clinical trials experience. Advanced degree preferred.

•Two or more years of supervisory experience of direct reports, and execution of multiple trials in parallel.

•Experience in all phases of clinical trials, in multiple geographies

•Required broad knowledge of clinical research and drug development

•Demonstrated success in independent clinical project management

•Specific and in-depth knowledge of ICH GCP and 21 CFR


General requirements :
work in tandem with Clinical Research, Regulatory Affairs, Biostatistics and Data Management, the clinical operations manager supervises an extended team to ensure timely and smooth execution of clinical studies, with full fiscal responsibility and adherence to applicable regulatory laws and regulations.
Technical requirements :
Experience in all phases of clinical trials, in multiple geographies
Candidates should have some experinence with :
7+ years of industry-sponsored clinical trials experience
Hiring Process:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email must) to ***srikanth.kadakanc@makrotech.com ***