ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Clinical Research Associate (CRA) Development Manager
Job Description:
Working as a Clinical Research Associate (CRA) Development Manager you will be responsible for coordinating the optimization of the performance and line management of the CRAs where a Project Manager is not allocated. In addition to this, you will line manage your team of CRA Development Coordinators; ensuring that they correctly and efficiently strengthen the clinical teams and development through careful coaching in accordance with internal SOP’s.
Additional Responsibilities:
* You will monitor and evaluate CRA’s workload and liaise with Resource Management and the Project Manager, to ensure appropriate allocation of resource and optimal utilisation of CRAs.
* Initiate regular communication, 1:1 meetings and assist appropriate mentors with all allocated CRAs (according to set goals) and coordinate CRA performance reviews and appraisals including obtaining feedback from PMs.
* Liaise with PMs/Director of Clinical Operations/Corporate Training as appropriate to ensure that training needs are identified, training is being provided and that allocated CRAs are working to a satisfactory standard.
* Accompany and ensure that CRAs are accompanied on pre-study, initiation, monitoring and close-out visits and provide on-site training for CRA evaluation and to assess performance and/or additional training needs. These visits should be conducted until the CRA has demonstrated the ability to conduct visits unassisted. All CRAs should have a minimum of one accompanied monitoring visit per year.
* Conduct regular CRA Forums to ensure CRAs are provided with relevant updates training as needed and provide feedback on the development implementation of formal CRA training tools and presentations.
* Assist with continuous review of current processes and implementation of process improvements and participate in business development activities.
Candidate Profile:
You will have previous CRA and line management experience and in addition you will have worked as a mentor/coach to staff members that are training as well as more qualified members of the team. Other expected qualifications are:
* Fundamental training experience with excellent training skills
* Background in medicine, science or other relevant discipline and appropriate experience
* Fundamental knowledge in Clinical Research, an expert in all phases of a clinical trial (PSV, set up, SIV, SMV, COV)
* Comprehensive knowledge and understanding of ICH-GCP
* Consistent track record of performing at or above expectations
* Ability to coordinate all aspects of clinical training
* Experience of managing other employees
* Proven experience of working successfully with clinical project teams
* Excellent interpersonal and communication skills
* Excellent written and spoken English in addition to fluency in the local language
* Competent computer skills
* Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees location, the employee may be required to possess a valid driver’s license
* Ability and willingness to travel approximately 50% – 60% of the time (international and domestic; fly and drive)
Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You’ll enjoy highly competitive compensation and an exceptional benefits package
ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.
Requirements:
* Candidate must possess at least a Bachelor’s Degree, Post Graduate Diploma, Professional Degree, BioTechnology, Dentistry, Medicine, Nursing, Pharmacy/Pharmacology or equivalent.
* At least 3 year(s) of working experience in the related field is required for this position.
* Preferably Managers specializing in Healthcare – Nurse/Medical Support & Assistant, Healthcare – Pharmacy or equivalent.
* Full-Time positions available.
Additional Information:
Experience: min. 3 years
Location: Delhi
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Clinical Research
Apply/Send resume at, malarkannan.j@iconplc.com
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