Position Summary: 

The CTM provides operational support to the program lead to ensure project milestones delivery on time, within budget, with high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines and applicable SOPs. This position will manage essential clinical trial duties and responsibilities as independently as possible, with guidance and oversight provided by leadership when needed. The CTM is also responsible for mentoring clinical research associates (CRAs) and clinical trial associates (CTAs), as appropriate.

Travel: Up to 30%

Essential Duties and Responsibilities:

• Responsible for all operational aspects and progress of clinical trial from a study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators
• Serves as an escalation point and resource for study team and investigational sites
• Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders
• Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Clinical Study Report (CSR) development, etc.
• Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate.
• Responsible for and participates in clinical vendor selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications  development, UATs, issues escalations).
• Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
• Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct.
• Creates, manages, measures, and reports timelines for milestone deliverables.
• Oversees/facilitates site feasibility/selection processes.
• Develops/oversees subject recruitment/retention strategy and related initiatives.
• Oversees internal team meetings, investigator meetings, and other trial- specific meetings.
• 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 that are 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

· 4+ years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO). Preference to candidates with prior small company experience and 1+ years management experience.

· Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required.

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: 

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

· Excellent sense of urgency to deliver at/surpass study conduct targets.

· Demonstrated ability to multi-task in a fast-paced small company environment with rapid changing priorities.

· Demonstrated ability to think “outside the box”.

· Demonstrated knowledge of GCP and ICH guideline knowledge base.

· Strong leadership skills, self-motivated, adaptable to a dynamic environment

· Demonstrated ability to problem solve, delegate appropriate tasks and/or develop junior team members.

· Demonstrated ability to manage a team of clinical research professionals working on a clinical trial program.

· Strong interpersonal skills and communication skills (both written and oral)

· Strong attention to detail and excellent organization skills

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.