Pharmacyclics, LLC

Clinical Trial Manager

Sunnyvale, CA
Mar 18, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type

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 indicators

· Serves as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional groups to achieve deliverables

· Oversees/facilitates country and site feasibility/selection processes

· Develops/oversees subject recruitment/retention strategy and related initiatives

· Provides 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 appropriate.

· Responsible 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/packages

· Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct

· Conducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed

Project Management:

· Creates, manages, measures, and reports timelines for milestone deliverables

· Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders

· Prepares metrics and updates for management

· Oversees internal team meetings, investigator meetings, and other trial­ specific meetings

· Participates in the development, review, and implementation of departmental SOPs, WIs, initiatives and processes

· May manage/mentor direct reports and team members, and perform performance appraisals as assigned

Financial Planning and Management:

· Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocation

· Collaborates in the development/management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines

· Reviews/approves vendor invoices and manages accruals and payment process for all clinical trial vendors including investigative sites

· Maintains completion of required corporate training on standards, policies, work instructions by due date

· Perform other work related duties as assigned


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

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

· Strong attention to detail and excellent organization skills

· Strong 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/vendors

· Demonstrates effective time management, multitasking and handles time sensitive demands, incomplete information or unexpected events

· Ability to problem solve, delegate appropriate tasks and/or develop junior team members as part of succession planning

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

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

· Supervision or other similar experience in a leadership or team management position

· Computer skills including proficiency in the use of Microsoft Word, Excel, Powerpoint, and organization tools

· Proficient in Sharepoint with filing systems is desirable

Education and Experience Requirements:

· 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)

· BA/BS or equivalent degree in scientific discipline. Advance degree preferred (MA/MS, PharmD, PhD)

· Experience in interactions with outside vendors, e.g., CROs and other vendors

· Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment

· Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a Clinical Development Plan

· Line management experience is required for Sr. CTM

· Experience in oncology preferred

· Experience in global trials preferred

Consideration 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.