AbbVie Senior Clinical Trial Manager in Sunnyvale, California

Senior Clinical Trial Manager

Location: Sunnyvale, CA

# of Openings: 1

Description

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

To learn more about us, please visit us athttp://www.pharmacyclics.com/

Pharmacyclics is seeking a Senior Clinical Trial Manager.

General Position Overview:

The Senior Clinical Trial Manager (Sr. CTM) serves in the role of the Clinical Trial Lead (CTL) acting as the primary operational contact for the study leading the cross-functional team for execution of the study. The Sr. CTM provides strategic and operational leadership to the clinical operations team to ensure project milestones deliver on time, within budget, high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions (WIs). The Sr. CTM should work independently and with minimal supervision; have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study or studies with effective communication across the organization. This position may include line management responsibilities.

Key Accountabilities/Core Job Responsibilities:

Study Planning and Conduct:

  • Models and encourages a culture of proactive and innovative goal setting, effectively articulating the vision of meaningful and measurable goals and objectives for the team; ensuringdirect reports’ goals are aligned to the department and corporate goals balancing buy-in across team and cross functional members while evaluating all performance aspects from study planning through execution tracking performance metrics and quality indicators

  • Recognizes cross functional or company-wide impact of problems and considers implications in solution management while serving as an escalation point and resource for internal/external teams and investigational sites

  • Oversees/facilitates country and site feasibility/selection processes

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

  • Provides operational, technical expertise and strategic input and/or approves study documents including but not limited to 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

  • Accountable for quality data and meeting timelines and providing guidance to study team as needed. Oversees the review of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures

  • 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 inspection readiness are maintained throughout study conduct

  • Participates in interim and final report preparation for regulatory submissions

  • Has a strong track record of meeting commitments and delivering high quality work on time performing Sponsor quality oversight of clinical staff or CRO performance adherence to GCP, corporate SOPs and protocol as needed

Project Management:

  • Demonstrates a clear understanding and distinction between critical and non-critical priorities, creating, managing, measuring and reporting project timelines for milestone deliverables; at times, this may require negotiating timelines with cross functional or external stakeholders

  • Serve as subject matter expert concerning scheduling of specific phases of study

· Proactively identifies/manages study risks and develops contingency plans for potential problems or obstacles with key internal/external stakeholders to deliver on deadlines and scope commitments

Financial Planning and Management:

· Strong understanding of study 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 including providing input to general study budgets, and identifying opportunities to reduce costs

People Management:

  • Being adept at diagnosing poor performance with methods of how performance may be improved and demonstrates managerial courage, timeliness, consistency, and tact in confronting and resolving performance issues, including cases when termination is required

  • Demonstrates mastery in coaching to suit individual needs and training study team members to plan, prioritize, develop analytical thinking, logic, problem resolution skills working toward being accountable for not only individual but team goal achievements

  • Willingly shares knowledge and expertise and enables ongoing feedback flow to the team, including specific performance feedback, including acknowledgement of accomplishments and corrective, as soon as possible after an event

  • Conducts ongoing performance management, performance reviews/appraisals and career development planning for all direct reports ensuring direct reports are in compliance with regulations, SOPs and protocol; May manage multiple clinical teams

General

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

  • Contribute expertise to departmental and cross-functional process improvement activities

  • Perform other work-related duties as assigned

Qualifications:

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

  • Ability to work on complex or multiple projects while soliciting ideas from others to form decisions and plans, fostering and recognizing mutually beneficial working relationships with people and departments to influence through formal or informal networking channels toward meeting objectives

  • Beyond having strong attention to detail and excellent organization skills should demonstrate the ability to compare and find optimum solutions, looking beyond the obvious, avoiding bias and historical crutches

  • Approaches interpersonal and communication engagements with energy, fostering active listening, carefully listening to other perspectives with respectfulness, transparency, i.e., assuring everyone has information needed to be effective and efficient and works toward conflict resolution with skillful composure and making decisions based on known facts

  • Ability to work effectively (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors, facilitating small and large meetings, promoting collaboration while accomplishing meeting objectives

  • Demonstrates a keen ability to assess group positions, intentions and recognize what teams value to effectively influence, empower, motivate others through encouragement, time management, multitasking, handling time sensitive demands, or unexpected events to achieve goals and objectives

  • Delegates appropriate tasks to team members based on risk, critical path, capability and to develop junior team members as part of succession planning

  • Demonstrates in-depth understanding of study protocol objectives, methodology and biostatistical concepts and data analysis on a global scale, global regulatory issues, CRO operations, and compliance practices as needed for effective study execution

  • Skilled at asking penetrating questions to define a problem situation and the ability to match individual capabilities to work toward solutions as a team thus creating high functioning teams as measured by successful on-time or surpassing project deliverables

  • Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint and organization tools

  • Proficiency in SharePoint with filing systems is desirable

Education and Experience Requirements:

  • BA/BS or equivalent training and/or experience. Advance degree preferred (MA/MS, PharmD, PhD)

  • 7+ years of clinical trial research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (with at least 1+ year at a Sponsor company is preferred)

  • 3+ years of line management experience

  • 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

  • Experience in oncology preferred

  • Experience in global trials preferred

Equal Opportunity Employer Minorities/Women/Veterans/Disabled