Senior Clinical Research Manager

Lawrence Harvey

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Job ID :

10028


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

North America,--New Jersey,New Jersey,


Key Skills :

Senior Clinical Research Manager


Salary :

Negotiable


Date Posted :

09 Jan, 2018



Company Name :

Lawrence Harvey


Location1 :

New Jersey




Job Category :

Biotech Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:



Writing and finalizing protocols for the conduct of interventional clinical trials and non-interventional trials as well as studies designed for the retrospective collection of data.

Selecting and qualifying sites for the performance of clinical trials.

Reviewing informed consent forms and other Trial Master File (TMF) documents, insuring that all regulatory requirements are met.

Performing site visits including monitoring activities as needed/assigned, insuring the clinical trial is being performed according to ICH/GCP guidelines and meeting the protocol requirements.

Planning, coordinating, and facilitating investigator meetings.

Communicating with study centers, addressing issues and disseminating study trial information.

Training investigators, monitors and site personnel to ensure appropriate collection and reporting of non-serious and serious adverse events, as well as special situations, and any urgent safety measures taken by the site during the study.

Assisting with data flow and query resolution.

Requesting and managing clinical supplies, including coordinating the shipment of the clinical supplies to study sites, over-seeing drug accountability and the return of clinical supplies.

Managing vendors and consultants (e.g., central ECG and lab services).

Insuring that all project information is up to date in CTMS (e.g. monitoring visits; enrollment).

Tracking enrollment for each site; proactively addressing issues, insuring protocol compliance.

Creating and maintaining Trial Master File

Initiating payments to investigators

Overseeing payments to vendors: reviewing invoices including documentation supporting pass through costs

Overseeing the tracking of receipt of original CRFs in house.

Submitting SUSARs to ECs and Investigators as needed.

Ensuring that projects keep within their approved budget.

Communicating critical study-related or personnel issues to the Head of CR in a timely manner to facilitate immediate action.



SECONDARY DUTIES AND RESPONSIBILITIES include the following:

Reviewing and commenting on documents circulated by other functions within GM&RA (e.g., IB; TLFs; Data Review Conventions; CTRs).

Providing input to the Head of CR for the Clinical Research budget estimations and re-forecasts when required.

Operational activities for approved IIS outside Europe, including periodic contact to sites within the United States and Canada; recording all information in CTMS; requesting contracts from Legal; attendance and participation at GIIRC; assisting Modality Leader with accruals and budgeting upon request.

CORE COMPETENCIES: Managing Clinical Trial Activities, Written and Verbal Communication Skills with particular attention to communicating study information, Managing vendors, Managing blinded readings,

EDUCATION and/or EXPERIENCE REQUIRED: B.S./B.A. degree. 3+ years Clinical Research/Management experience with demonstrated experience in multi-national and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines.



Strong organizational, communication and team work skills. Ability to manage several projects simultaneously.

CERTIFICATES, LICENSES, REGISTRATIONS: None required.

Travel is required (20%).

The position is office based.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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