Position Summary: 

The Sr. CTM is the lead operational contact for the study and provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by leadership when needed. 

Essential Duties and Responsibilities:

• Responsible for all operational aspects and progress of assigned clinical trial from a study planning activity to study      execution including ongoing tracking all applicable performance metrics and quality indicators for milestone deliverables
• Provide expertise and operational input into protocol synopsis, final protocol and other study related documents
• Participate in country and site feasibility/selection process
• Create and maintain timelines to meet the needs of the assigned clinical study(ies)
• Ensure new team members and vendors are onboarded
• Lead the development of the operational strategy in preparation for review; focus on ensuring accurate assumptions are applied and risk management plans are in place
• Provide guidance to CRO/vendor to ensure study issues are addressed and resolved
• Work to ensure that budgets, enrollment, and gaiting are maintained and accurate; communicate study status, cost and issues to Project Leader(s); serve as escalation point for vendors or other CROs
• Support CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities      assigned to a CRO/vendor for assigned studies, including escalation of  issues to governance committees when warranted
• Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including      review of site regulatory documents/packages
• Specific areas of sponsor oversight include:
  • Approval of essential monitoring documents/plans,  periodic review of outputs and actions related to monitoring
  • Review and endorsement of relevant study plans, as  applicable
  • Study team meeting management and attendance; regular  review of meeting agendas and minutes
  • Review outcomes/actions related to protocol deviations  review; primary purpose of review is to help identify trends across sites or the study
  • Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies
  • In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between       the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR
  • Ensure studies are "inspection ready" at all time; may be involved in regulatory inspections by preparing for and       attending the inspections
• Represent Clinical Operations Manager role in functional projects or working groups
• Help with onboarding and mentoring of new Clinical Operations Team members
• Knowledge of regulations as it relates to ICH GCP 
• Participates in the development, review, and implementation of departmental SOPs, initiatives and processes
• Reviews/approves vendor invoices for all clinical trial vendors including investigative sites

Other Duties:

· Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Required Education and Experience:

· BA/BS

· 6 or more years of clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO), with a focus on clinical operations.

· Experience with the following:

o Developing and writing study protocols, study procedure manuals, informed consent forms, clinical study reports and other study plans/documents

o Leading outsourced studies across all functional areas (preclinical, stats, data management, and medical writing)

o Vendor oversight including operations and budget

o Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results

• Willingness to travel as needed, up to 30% including      overnight and international travel

Required Knowledge, Skills, Abilities & Behaviors: 

Strong GCP and ICH guideline knowledge base; ability to multi-task; ability to manage a team of clinical research professionals working on a clinical trial program; strong verbal and written communication skills; flexibility

Work Conditions:

· This job operates in a professional office environment

· This role routinely uses standard office equipment such as computers, phones and photocopiers

· This position is required to work occasional nights and weekends to meet company demands 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Occasional travel is required via automobile, train, bus and/or airplane

While performing the duties of this job, the employee is occasionally required to stand; walk; use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell. 

The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.