Suljettu

Clinical Project Manager (Ophthamology / Gene Therapy)

Job details

Salary

$500 - $750 a day

Job Type

Contract

Full Job Description

Description

I’m working with a fast growing ophthalmology / gene therapy focused biotech who are seeking multiple Clinical Project Managers across the UK and US to join a dynamic team responsible for the oversight planning and execution of assigned clinical studies to support product development.

This role will be responsible for all assigned studies – clinical operational oversight as well as the execution of monitoring of study deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans?and supporting third party vendor relationships.

Overseeing new clinical studies within their developing pipeline

Working with fellow operational team members to ensure consistent operational execution over study program

To be an active member of the operational team and help drive the department’s evolution and success

To adopt a ‘site-centric’ role creating relationships with assigned key sites, Investigators and site personnel

Role Responsibilities:

Responsible for the oversight and day-to-day management of clinical operations activities

Ensure that the planning, implementation, coordination and reporting of the clinical studies in line with the corporate objectives

Act as a key study contact for studies and effectively plan and communicate study milestones, deliverables, timelines and quality standards to other functions and other stakeholder groups

Support and mentor team of Associate Clinical Project Managers/Clinical Trial Associates assigned to studies

Support and monitor CRO and third-party vendor activities, including IMP management, Investigator contract/budgets, TMF management, study set-up, project management, biostatistics and medical writing

Monitor progress of studies, identify study-related trends/issues and work with the Senior Clinical Operations team to implement corrective actions when necessary

Attend site visits (including, but not limited to, Site Initiation Visits and study surgeries) where local and national travel policies allow

Work with the study team to develop recruitment strategies

Through adoption of a site centric model, liaise directly with assigned sites to ensure maintenance of site relationships, troubleshoot study related issues and impart key messaging to the site

Prepare and/or review Study Plans, Vendor Specifications and Scopes of Work

Contribute to the preparation, design and/or review of essential regulatory study documents, ethics and other required local/national submission requirements

Drive the identification and selection of clinical trial investigators as per clinical operations strategy

In conjunction with Surgical Technical Expert Liaison, oversee execution of the Surgical Training Plan

Adopt a Risk Management approach to oversight and execution of assigned clinical studies

Coordinate with CMC for the shipment of IP and ancillary supplies to investigator sites

Coordinate and/or lead contract and budget negotiations with sites and third-party vendors

Lead study operational and/or scientific feasibility, and site set-up activities as per clinical operations strategy

Prepare study training materials and present at Internal Workshops and Investigator Meetings

Set up and chair study meetings when required

Ensure study certifications, insurance, licenses and registrations are maintained

Cross Functional Interactions:

Taidot: Tiedonsyöttö

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Tietoa työnantajasta:
( 0 arvostelua ) Lagos, Nigeria

Projektin tunnus: #29411395

11 freelanceria on tarjonnut keskimäärin $27/tunti tähän työhön

KNami

Hi Recruiter, I have just gone through the details shared by you an would like to show my interest in the work. I am a medical professional with 5 years of experience in medical domain. experience with management, bu Lisää

$100 USD / tunti
(1 arvostelu)
2.2
sehrawala

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$15 USD / tunti
(1 arvostelu)
1.4
khadijasonia14

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$20 USD / tunti
(0 arvostelua)
0.0
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$21 USD / tunti
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0.0
Mahinder1234

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$18 USD / tunti
(0 arvostelua)
0.0
sonusharma89897

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$20 USD / tunti
(0 arvostelua)
0.0
(0 arvostelua)
0.0
Aryan618

Hi, I am a medical [login to view URL] I have some important knowledge about the clinical project and how to write this type of work done. I have knowledge about the opthalmology and also in gene therapy. So I hope you apprecia Lisää

$15 USD / tunti
(0 arvostelua)
0.0
gehanghazaly

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$20 USD / tunti
(0 arvostelua)
0.0
Asadshaikh503

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$25 USD / tunti
(0 arvostelua)
0.0
Shezad850

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$20 USD / tunti
(0 arvostelua)
0.0