Apple & Associates, Inc.
Top Tier Pharmaceutical company (with focus in RESPIRATORY, CNS, Diabetes, Cardio, GI and more) in Madison, NJ
is looking for three Clinical Trials Manager Consultants for Clinical Trials Group
This is a one year contract and can continue for up to 4 years
(1099 or w-2)
Participate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials
CTM – GENERAL JOB DESCRIPTION (snr would be just a bit more experience and ability)
I. ROLE SUMMARY:
Responsible for supporting the Senior Clinical Trial Manager/operational study lead, and for managing various aspects of the operational execution and delivery of quality studies, including in process quality control activities (e.g. quality checks and balances to ensure inspection readiness, Enrollment, Metrics, Milestones, Timelines and Budget)
II. PRIMARY JOB RESPONSIBILITIES:
Primary responsibilities of this position include:
•Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
•Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies.
•Responsible for monitoring assigned aspects of the study operational plan.
•Responsible for managing assigned aspects of the operational study budget, timelines, and risk mitigation processes with input from key stakeholders
•Supports the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
•Responsible for supporting the management and maintenance of the study TMF
•Supports the Sr. CTM in managing the selection, contracting and oversight of CROs and clinical trial related vendors in collaboration with the study team and key stakeholders
•Responsible for supporting the development and management of various aspects of the integrated study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders inclusive of all operational accountabilities (e.g. Clinical Planning, RA, GDS, PR&D, R&D QA).
•Responsible for providing support for, and input into, the development, implementation, management of standard tools used to manage study (e.g. quality and performance metrics, timelines, critical path activities, milestones) and resources (e.g. timelines, budget, vendors, other)
•Responsible for supporting, and providing input into, the development, UAT, and roll out of EDC/eCRF and eHELP (i.e. completion training guidance)
•Responsible for supporting, and providing input into, the setup of CTMS set-up, MUL (master user list), study specific internal and site training
•Responsible for supporting the management of core processes (e.g. Site management, investigator notification letters, protocol deviations, study feasibility and enrollment) with input from key stakeholders
•Responsible for supporting the management of Trial Master File (e.g. setup and ongoing maintenance of TMF documents and documentation process/plan)
Study Start Up Activities:
•Responsible for supporting the management of Non-Drug Site Supplies (study materials/equipment,/manuals), deliverable development, shipment, tracking and resupply to sites
•Responsible for supporting the management of IRB submission process for start-up (Protocol and other study documents); Annual update process, Protocol amendments and study close out
•Responsible for supporting the tracking of study vendor activities, milestones, materials per specifications and the contract
•Responsible for supporting the oversight of CRO Management (specifications, country/site selection, start up, conduct, close out, budget/invoices) with input from key stakeholders
Study Drug Management:
•Responsible for supporting the management of the drug supply process (e.g. recruitment hold, enrollment extension) with input from key stakeholders
Pharmacovigilance/SAE/AE Handling and Reporting:
•Responsible for supporting the distribution and tracking of alert letters to IRBs
•Responsible for supporting the development and management of process for identifying duplicate patients
•Responsible for supporting, and ensuring, documentation of medical monitoring finding/decisions/discussions for TMF
CSR Development and Reporting:
•Responsible for providing operation support into the CSR
III. JOB QUALIFICATIONS:
Minimum of 3-5 years of pharmaceuticals/biotech experience
Minimum of 3-5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
Process and system thinking, customer orientation, and ability to work in multidisciplinary study teams and to execute within a matrix management model, ideally in pharmaceuticals/biotech.
Experience in execution of clinical research trials, including GCP and regulatory guideline knowledge and audit inspections.
Knowledge and experience in clinical study budgeting including timeline and the application of clinical trial performance metrics
Demonstrated ability to support the development and management of various aspects of the end to end study operational plan
Demonstrated ability to support the operational execution and delivery of various aspects of a quality clinical trial
Demonstrated experience in change management initiatives preferred
Program and project management experience preferred
International experience a plus
Knowledge, Skills, and Abilities
Knowledge of drug development and FDA GCP/ICH regulatory guidelines
Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc.
Clinical trial management system (CTMS) background is a plus
Strong ability to work within a matrixed organization, managing multiple tasks in a timely, budget-conscious manner
Ability to identify and work with key stakeholders to deliver operational requirements
Ability to consistently operationalize abstract ideas
Ability to identify issues, analyze situations and provide effective solutions
Must possess demonstrated skill in the following:
Decision-making, Judgment, and Problem Solving
Interpersonal relationships, team building, motivating & mentoring associates and influencing others
Initiative and Accountability
Promoting Innovation and Process Improvement
Strong oral and written communication skills
Ability to embrace change and comfortable with ambiguity
At Apple & Associates, we understand that relationships are what make us stand apart. Whether you are a client or a candidate, you are an extension of the Apple & Associates’ family. Many of our recruiters have been with the company since its earliest days. They take great pride in the relationships they build; always emphasizing high standards, ethics and quality service. Our President, Debi Apple started her recruiting career in Aiken, South Carolina. She quickly became a top producer and leading authority in recruiting for the medical device, pharmaceutical and consumer product industries. Her passion and drive led her to open Apple & Associates in 1993. Under her leadership, Apple & Associates has grown to be one of the leading recruiting firms in these industries. Our company is proud to represent two of the largest medical device and pharmaceutical companies in the U.S., Covidien (formerly known as Tyco Healthcare) and our first and longtime client, Becton Dickinson. Now headquartered in Chapin, South Carolina, Apple & Associates has offices from coast to coast, offering regional recruiting expertise throughout the U.S. and Latin America. Our searches and permanent placements represent all levels, from CEO to staff level positions.