Senior Clinical Operation Lead

Position Details: Client Direct Client Location Cambridge, MA Job Title Senior Clinical Operation Lead Duration 1year+ (possible extension) Must have skill-set [Job Description] JOB RESPONSIBILITIES: • Partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols. • Leverage Phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy. • Independently oversees one or more trials by establishing the operational strategy and securing excellence in execution through the CRO partner. • Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans • Leverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issues • Ensure all operational aspects support end point integrity and data validity. Has a robust understanding of the study design including rationale, end points and patient population, and will ensure that the operational strategy supports both feasibility and scientific integrity. • Leverages Phase expertise (e.g. Phase I, II, III, and IV), therapeutic knowledge, as well as internal and external data to develop protocols and expert operational strategy for one or more clinical studies. KNOWLEDGE, SKILLS & ABILITIES: • At least 10 years of clinical research study management experience of which at least 4 years has been with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations a plus. Prior CRO or investigator site and/or monitoring experience is a plus. • Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development. Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas. • Ability to establish operational plans and support the CRO in the execution of the plans. Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organization. • Excellent project management skills, including risk assessment and contingency planning. Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model. • Able to partner with other functions and both internal and external stakeholders. Excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills. • Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development. • Strong Early Phase experience, preferably in Phase O or the Scientific Research Collaboration area. • Creative thinking to solicit support for the varying aspects of the studies. • Early clinical research experience (basic research experience is a plus, but not a requirement). • In-depth understanding of the regulatory and ethical environment across countries and regions for IMP and NIMP studies. • Ability to scientifically understand protocols and provide input on all operational aspects in order to inform the development of an effective operational strategy. • Ability to quickly adapt to flexible clinical processes, emerging science, and new evolving trial methodologies. • Ability to adapt to a flexible frame of work and comfortable with the unknown. Pre-Employment Questions: If you would like to pursue this position, please reply to this e-mail and provide us details in following areas. Also, please attach a copy of your updated resume, in word format, elaborating your projects in tune with the client’s requirement. This will assist us in placing you with one of our clients. Ø What is your expected yearly salary or hourly rate? Ø Please provide details about your education background – Qualification, Name of School, City & State Ø Are you currently on any assignment? Is your current assignment contract or permanent? Ø If given this opportunity, how soon would you be able to start on this project? Ø Are you authorized to work for any employer in the US? Ø Have you ever been convicted of a criminal offense? If yes, please explain and provide details: Note: Do not include convictions that have been annulled, erased, expunged, vacated, set aside, sealed by a court, or referred to a diversion program. Conviction of a crime will not necessarily disqualify you from employment. Factors such as age at the time of the offense, seriousness and nature of the violation, and rehabilitation will be considered when making employment decisions. A conviction record will not necessarily be a bar to employment. Ø Do you have any disabilities that prevent you from successfully performing the essential functions of this job with or without accommodations? Ø What is your home phone number? Ø What is your cell phone number? Ø On which e-mail ID do you wish to receive further communications in regards to this position? Ø What is the best time for me to reach out to you for discussing this opportunity in detail? Ø What is the best way to reach you in case an interview is scheduled? Feel free to forward my email to your friends/colleagues who might be available Thanks!!! Warm Regards, Amrit Singh Clinical Recruiter Integrated Resources, Inc IT REHAB CLINICAL NURSING Tel: (732) 429 1634 Fax: (732) 549 5549 Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70 A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.