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Senior Clinical Project Manager, Medical Device (Home-Based, Europe) - IQVIA Biotech

Employer
IQVIA Biotech
Location
Europe
Salary
Competitive
Start date
25 Jul 2019
Closing date
24 Aug 2019

Job Details

IQVIA Biotech is the global, enterprise-wide solution that provides flexible, tailored, integrated clinical and commercial solutions to small biotech and pharmaceutical companies, from planning through trial design and implementation to launch and commercialization.

We recognize that the needs of small companies are different than large companies, so we developed a separate business unit within IQVIA which provides a high-touch solution with high levels of service and hands-on attention, with the benefits of IQVIA’s data and expertise – including powerful analytics, resources, therapeutic experts and global footprint.

IQVIA Biotech has five therapeutic divisions. Complementing our successful history in Oncology, we have dedicated delivery teams in General Medicine – which includes Dermatology, Cardiovascular/Renal/Metabolics, Central Nervous System and Immunology.

IQVIA Biotech are currently hiring an experienced Senior Clinical Project Manager to join our Medical Device (MedTech) team. 

Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial.  Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by IQVIA Biotech and sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Responsible for all activities related to implementation of clinical studies including:

·Manages projects of full scope regional and global projects.  Responsible for project team leadership

·Responsible for building and maintaining positive  client relationships

·Ability to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained, projects are done within scope

·Reviewing and identifying project study trends and proactively responding to client and respective team members

·Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges

·Responsible for change management on all assigned projects

·Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract

·Responsible for assuring project timelines are met as per contract

·Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead

·Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware

·In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.

·Provide other project support to Managers, as assigned

·Oversee delegation of support staff activities, as necessary

·Assists in the development and delivery of capability and proposal defense presentations to prospective clients

·Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team.  Represents senior management in negotiation of contracts as appropriate.

·Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually

·Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.

·Responsible to maintain personal currency documentation for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office

KNOWLEDGE, SKILLS AND ABILITIES:

·Thorough knowledge of clinical research process from Phase I through regulatory submission

·Strong communication skills (verbal and written) to express complex ideas

·Excellent and demonstrated organizational and interpersonal skills

·Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities

·Ability to manage multiple priorities within a variety of complex clinical trials

·Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings

·Ability to set baseline targets, track trends and implement mitigation plans

·Understanding of basic data processing functions, including electronic data capture

·Demonstrated problem-solving and financial negotiation skills 

·Working knowledge of current ICH GCP guidelines

 

Please contact me today for full details and to discuss on a confidential basis.

Company

IQVIA Biotech is the global, enterprise-wide solution that provides flexible, tailored, integrated clinical and commercial solutions to small biotech and pharmaceutical companies, from planning through trial design and implementation to launch and commercialization.

We recognize that the needs of small companies are different than large companies, so we developed a separate business unit within IQVIA which provides a high-touch solution with high levels of service and hands-on attention, with the benefits of IQVIA’s data and expertise – including powerful analytics, resources, therapeutic experts and global footprint.

IQVIA Biotech has five therapeutic divisions. Complementing our successful history in Oncology, we have dedicated delivery teams in General Medicine – which includes Dermatology, Cardiovascular/Renal/Metabolics, Central Nervous System and Immunology.

Interested in being a part of this exciting and dynamic team?

Contact us today to find out more!

 

Company info
Website
Telephone
+44(0)1438 221122
Location
Ground Floor
Abel Smith House
Gunnells Wood Road
Stevenage
Herts
SG1 2ST
United Kingdom

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