Senior Clinical Project Assistant

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 at http://www.pharmacyclics.com/

Senior Clinical Project Assistant

General Position Summary/Purpose:

The Senior Clinical Trial Assistant (Sr CTA) ^[1] provides support to the clinical study teams in the execution of clinical trials. Primary responsibilities include maintaining Trial Master File (TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, assisting with site management, initiating collection, reviewing and tracking of essential documents throughout the life of the trial. Contributes to the production and distribution of study materials and site/study communications.

Key Accountabilities/Core Job Responsibilities:

Study Planning and Conduct:

Establishes and maintains the TMF and CTMS. With minimal supervision of the CRA, CTM or Study Lead, the Sr. CTA will review the CTMS/TMF for compliance, addressing findings as needed and supporting the study team with study activities

Assists clinical operation leads in the development, handling, distribution, filing and archiving of essential documents in the TMF

Assists and/or contributes to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans, study communications and presentations

Handles incoming and outgoing clinical trial related materials shipments to site, study team, CRAs and vendors, as needed

Assists with all aspects of initial study drug release including regulatory packet review and study-drug release

Assists clinical study team with the planning, preparation, and on-site support of investigators meetings.

Assists in the development of case report forms and participate in the EDC and IXRS specification process, as appropriate

Communicates directly with sites, Site Management Organizations (SMOs), Contract Research Organizations (CROs) and field CRAs to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close out activities

Ensures timely study entry and updates to ‘Clinicaltrial.gov' and maintains until end-of-study under supervision

Assists with tracking of clinical trial progress including status updates reports, as requested

Assists with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, and other documents, as required

Participates in clinical teams, including attending required meeting, and interacts in a positive, professional manner. May coordinates meetings/teleconference/WebEx. Prepares agendas, minutes and tracks action items.

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

Identifies and escalates issues appropriately

Performs other work-related duties as assigned

Qualifications:

Understanding in relevant clinical operations activities

Ability to exercise judgment within generally defined practices and policies that lead to methods or processes for obtaining results under supervision

Basic knowledge and understanding of ICH/GCP guidelines and FDA regulations required

Working knowledge of TMF maintenance and management of essential documents

Solid interpersonal, written and verbal communication skills across study team including study management

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

Experience in Sharepoint with filing systems is desirable

Attention to detail and accuracy in work

Effective time management and organization skills

Ability to multi-task under limited direction and on own initiative

Performs other work-related duties as assigned

Education and Experience:

BA/BS or equivalent degree in a scientific discipline, RN, or related field is preferred but not required

1-3 years experience in the pharmaceutical, biotechnology, CRO and/or healthcare setting

Demonstrate basic understanding of medical terminology and clinical activities in relation to execution of Clinical Development Plan

Working knowledge of regulatory documents and TMF maintenance

Key Accountabilities/Core Job Responsibilities:

Study Planning and Conduct :

Acts as primary point of contact for vendors, investigational sites and cross functional teams and escalates to the study lead as necessary

Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents including contracts/site payments Supports in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT

Responsible for oversight and mentoring of junior team members

Performs and may lead in-house review of clinical data listings for completeness and accuracy and escalate issues to the CTM or above as needed

Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics

Responsible for the development and distribution of study newsletters, tracking and reporting of recruitment updates

Participates in the selection, training, and evaluation of study personnel (contractors, CRO, internal)

Assists with providing oversight of CROs, , independent CRA and vendors including managing cross-functional teams

Reviews monitoring trip reports and track resolution of all action items

May participate in site visits as needed or accompany junior team members for training purposes

Project Management:

Collaborates with internal cross functional teams (i.e., Clinical Science, Biometrics, Regulatory Affairs, etc.), to ensure effective delivery of the assigned project milestones

Organizes and manages internal team meetings, investigator meetings, and other trial­ specific meetings as required

Financial Planning and Management:

Provides support to the CTM in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments

General:

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

Performs other work-related duties as assigned

Qualifications:

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 critical thinking with minimal supervision

Solid attention to detail and excellent organization skills

Solid interpersonal skills and communication skills (both written and oral)

Ability to establish priorities, excellent sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors

Demonstrates problem solving skills Demonstrates leadership skills, self-motivated and adaptable to a dynamic environment

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

Proficient with Sharepoint with filing systems is desirable

Education and Experience Requirements:

BA/BS or equivalent degree in a scientific discipline or related healthcare field is preferred but is not required

Minimum of 5 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 2+ years on-site monitoring experience)

Demonstrates core understanding of medical terminology or clinical trial activities

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

Experience in oncology preferred

Experience in global trials preferred