General Position Overview:The Clinical Trial Manager (CTM)/Sr. CTM (level is depending on experience) is the primary operational contact for the study and leads the cross-functional team for execution of the study. The CTM 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 Authorities' regulations/guidelines, and applicable SOPs/Work Instructions (WIs). The CTM should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study (ies) with effective communication across organization. This position may include line management responsibilities.Key Accountabilities/Core Job Responsibilities: Study Planning and Conduct: 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 indicatorsServes as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional groups to achieve deliverablesOversees/facilitates country and site feasibility/selection processesDevelops/oversees subject recruitment/retention strategy and related initiativesProvides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, 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 appropriateResponsible for and participates in clinical service provider (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)Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and vendors Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packagesEnsures that all aspects of GCP compliance and audit readiness are maintained throughout trial conductConducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as neededProject Management: Creates, manages, measures, and reports timelines for milestone deliverablesProactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholdersPrepares metrics and updates for managementOversees internal team meetings, investigator meetings, and other trial specific meetingsParticipates in the development, review, and implementation of departmental SOPs, WIs, initiatives and processesMay manage/mentor direct reports and team members, and perform performance appraisals as assignedFinancial Planning and Management:Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocationCollaborates in the development/management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelinesReviews/approves vendor invoices and manages accruals and payment process for all clinical trial vendors including investigative sitesMaintains completion of required corporate training on standards, policies, work instructions by due datePerform other work related duties as assignedQualifications:Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is requiredAbility to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining resultsStrong attention to detail and excellent organization skillsStrong interpersonal skills and communication skills (both written and oral)Ability to work effectively (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendorsDemonstrates effective time management, multitasking and handles time sensitive demands, incomplete information or unexpected eventsAbility to problem solve, delegate appropriate tasks and/or develop junior team members as part of succession planningExcellent sense of urgency to deliver at/surpass study conduct targetsStrong leadership skills, self-motivated, adaptable to a dynamic environmentSupervision or other similar experience in a leadership or team management positionComputer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization toolsProficient in Sharepoint with filing systems is desirableEducation and Experience Requirements: BA/BS or equivalent degree in scientific discipline. Advance degree preferred (MA/MS, PharmD, PhD)Minimum 7-8 years of clinical trial research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting with 1 year of supervisory experience for Sr. CTM (at least 1 year at a Sponsor company is preferred for both levels)Experience in interactions with outside vendors, e.g., CROs and other vendorsFamiliar with advanced concepts of clinical research and able to work effectively in a team/matrix environmentDemonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a Clinical Development PlanLine management experience is required for Sr. CTMExperience in oncology preferredExperience in global trials preferredConsideration for Sr. title will be based on previous experience and/or education Clinical Trial Manager Core Competency: Can independently manage various stages of clinical trial, entire study execution; Cross functional leader (go to person with great communication skills); Working knowledge of budget/finance of clinical trial; May have line management skills. Senior Clinical Trial Manager Core Competency: Independently driving and executing all aspect of a trial - global experience required, number of years, complexity, and size of the study preferred; Strong budget/finance experience; Proficient in appropriate delegation and efficient reporting to Senior Management; Lead study-wide cross functional aspects seamlessly; Line management experience required.About Aerotek:Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit aerotek.com.
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Aerotek is a leader in the recruiting and staffing industry. With nearly three decades in the recruiting and staffing industry, we have developed the knowledge and skills to deliver the perfect fit between a candidate and an employer. Aerotek was founded in 1983 to service the recruiting and staffing needs for the aerospace and defense industry. Due to Aerotek’s rapid growth and success, we’ve continued to expand our services to provide recruiting and staffing to many industries focusing on technical, professional and industrial staffing.