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Clinical Team Lead

Covance 3/22/2018 6:35:59 AM
JOB ID: 18564 Category: Clinical Operations
Princeton, New Jersey

   

 

Job Overview

Clinical Team Lead (Sponsor Dedicated & home based)

Are you ready to make a truly rewarding career change? In this unique CTL position you will work closely with an exciting Pharmaceutical client in the cutting edge area of Oncology!

The CTL is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project on a regional or global level, as assigned. The CTL is responsible for coordinating and managing the clinical operations and global site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope). This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.

* Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business, as required.

* Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters. Meet/exceed client satisfaction expectations.

Initiation and PlanningSite Start-Up

* Leads site selection team during study start up. Depending on size and scope of project, may be

performed in collaboration with other project team members.

* Provide input into the development of site selection feasibility materials; obtain country feedback for potential investigators both from Clinical Operations and Global Site Services and support set up of investigative site in CTMS.

* Requests, manages and tracks clinical project resources and needs including Site ID CRAs.

* Evaluates site profile for selection pre and post-PSV. Provides input to SUPM.

* Responsible for PSV trip report review and approval.

Overall

* Sets the project related clinical operations objectives and strategy in collaboration with the Core Team.

* Accountable for budget control across the Clinical Operations department for assigned project (s) and ensuring billing guide is modified to align to contract and any change orders. Accurate month to month completion of earned value analysis and evaluation and management of billed time to project(s) to minimize write off. Proactively identify out of scope work.

Proactively identify and mitigate project inefficiencies to stay within budget.

* Provides clinical operations input into cross functional project plans.

* Develops the risk and contingency plans for key clinical operations activities in collaboration with the Core Team.

* Manages the successful design and finalization of the Monitoring Plan and clinical operation training plans for assigned projects.

* Provides clinical support to Global Site Services for regulatory submissions and IRB/ERC queries.

* Assists in the design ofthe CRF, EDC or equivalent.

* Owns the development of project-specific site, operational tracking and monitoring tools (inclusive of CTMS tools and other system tools customized for clinical staff).

* Owns the development of training materials and training specific to the clinical operations team.

* Plans, develops materials and presents the training materials for Investigator Meetings.

* Responsible for development and finalization of the trip report templates.

Execution

* Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans.

* Responsible and accountable for the clinical operations budget for the project. Ensures that clinical operations activities are within budget and scope.

* Responsible and accountable for managing the clinical operations timelines as agreed with the client.

* Participates in internal project review meetings and provides operational and regulatory maintenance updates to the project management team and Sponsor.

* Liaise with Sponsor and Covance Regulatory Submissions regarding maintenance of regulatory documentation and ongoing submission requirements.

* Coordinates and oversees IRB/IEC/regulatory document collection, processing and maintenance activities following start-up in accordance with the Investigator Package Plan, with overall accountability to timeline, budget and quality. Ensures document tracking information is included and updated in CTMS.

* Responsible and accountable for study specific revision and maintenance of Monitoring Plan, Resource Management Plan for Clinical Operations, and Training Plan for Clinical Operations

* Coordinates revisions to the IPP, Document Maintenance Plan, SABP, RESP and CSSP, as required.

* Responsible for the clinical management of approved sub-CROs. May also be requested to manage approved vendors for clinical activities or services.

* Ensures that all clinical operations staff allocated to assigned projects adhere to professional standards, ICH/GCP guidelines, project plans and SOPs.

* Ensures appropriate utilization of all assigned clinical operations team members.

* Responsible for timely and appropriate communication to the clinical operations team.

* Provide performance feedback of team members to respective supervisors.

* Ensure accurate and timely trip report completion and trip report review.

* Review and approve investigator grant and IRB/IEC/regulatory payments

* Follow project issue escalation process and Covance's Corrective Action Issue Resolution (CAIR) process for clinical operations issues.

* Responsible for clinical operations Corrective and Preventative Action plans.

* Performs co-monitoring visits when necessary.

* Ensure timely filing of relevant sections of the TMF.

* Responsible and accountable for review and maintenance of relevant sections of the TMF. Fully accountable for completeness and quality of the investigator files.

Monitor and Control

* Monitor, track and report progress against client project metrics related to IRB/IEC/regulatory maintenance and clinical operations deliverables.

* Owns and implements the risk and contingency plans for IRB/IEC/regulatory maintenance and clinical operations activities.

* Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects

* Track project progress against financial milestones using applicable financial systems. Review Time Analysis and provide monthly hours forecast.

Close-Out

* Consolidates resources to ensure financial viability during close-out.

* Ensures all site issues have been resolved.

* Ensures clinical operations sections of the central TMF are complete.

* Ensures investigator documentation (including IRB/IEC/regulatory documentation) is complete and audit ready.

* Coordinates archival of the central clinical operations and investigator sections of the TMF. The CTL may perform other tasks as assigned by the project team throughout the course of the project.

Education/Qualifications

Required:

* University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.

* In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research Experience in pharmaceutical, CRO industries or Experience in a health care setting will be considered.

* Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.

* Thorough understanding of the drug development process.

Preferred:

* Working knowledge ofCovance SOPs.

* Experience as a Senior Clinical Research Associate, whether internal or external.

Experience

* Experience as a Senior Clinical Research Associate, whether internal or external.

* Minimum of five (5) years of relevant clinical research Experience with an ability to demonstrate comprehensive understanding of:

* ICH/GCP guidelines;

* Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;

* Site monitoring and study site management requirements;

* Applicable regional regulatory requirements;

* Trip report review, risk planning, study plan development, resource planning and data management oversight.

* In lieu of the above requirements, candidates with> two (2) years supervisory Experience in a. health care setting and four ( 4) years clinical research Experience (including monitoring) in the pharmaceutical or CRO industries will be considered.

Additional requirements include:

* Demonstrated ability to work with minimal supervision.

* Demonstrated good planning and organization skills.

* Good computer skills with good working knowledge of a range of computer packages.

* Demonstrated effective and professional verbal and written communication skills.

* Ability to train, lead and develop junior staff.

* Ability to understand and work with financial information.

* Ability to resolve project-related problems and prioritizes workload for self and team.

* Ability to work collaboratively within a project team.

* Ability to work efficiently and effectively in a matrix environment.

Preferred:

* 1+ year's additional Experience in a related field (i.e. medical, clinical, pharmaceutical,

laboratory, research, data analysis, data management or technical writing) is preferred.

* Local project coordination and/or project management Experience .

* Thorough knowledge of Covance SOPs regarding site monitoring.

Experience WORKING DIRECTLY WITH A SPONSOR is strongly preferred.


Position Type: Full-Time

Location: Princeton, NJ - New Jersey



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).