Manager, Clinical Research Associate (Full-time or Part-time)

Emmes Services Pvt. Ltd , ("Emmes") is searching for Manager Clinical Research Associate in Clinical Research located in our Bangalore, India office. Emmes provides flexibility for office location preference, dependent upon position.

EMMES Services Pvt. Ltd, Bangalore, a fully owned subsidiary of The Emmes Company, LLC. Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

This position will provide expert advice, guidance and general supervision to clinical monitoring team activities for designated projects, and will monitor specified sites to ensure quality and integrity of data, compliance with standard operating procedures (SOPs), clinical monitoring plan, ICH GCP, regulatory requirements, ensuring study completion on time and within budget.

Responsibilities

  • Ensure smooth conduct of clinical trials that include operational, data management, regulatory and protocol development activities associated to the trials.
  • Mentor junior team members on technical and behavioral aspects of the role and conduct their performance reviews.
  • Participate in interviewing for the monitoring team.
  • Oversees site visits to determine protocol and regulatory compliance and prepares required documentation (co-monitoring visits) .
  • Leads the execution of site contracts and contract negotiations with Investigators.
  • Responsible for working with CRA Director to ensure quality, cost effectiveness, and timeliness of clinical trials.
  • Maintain metrics related to site assessments, feasibility and selection, site progress, and close out activities.
  • Liaises with other departments to revise/create and implement monitoring documents (monitoring checklists, templates, etc.).
  • Ensures that the professional activities of the department meet corresponding country regulatory requirements.
  • May track clinical trial budgets, investigator payments, and coordination of studies.
  • Participate in corporate QA activities through Internal Quality Audit Team (IQAT), develop compliance/Variance table, and internal/ external audits as applicable.
  • Build and continuously improve project and corporate material that include SOPs, Manual of Operating Procedures (MOPs), Monitoring Plans, User's Guides and Handbooks.
  • Responsible for review of clinical trial documentation, case report forms, protocols, monitoring plan, monitoring report templates, and informed consent/assent documents etc. in accordance with project and regulatory requirements. Responsible for the maintenance and development of project materials such as project Standard Operating Procedures (SOPs), Manual of Procedure (MOP), User Guides, etc.


PHYSICAL DEMANDS

The physical demand of this job is that of a normal Emmes' Office Environment or work-from-home (depending upon the location).

TRAVEL

May travel up to 70% to clinical study sites within India or across geographies.

EDUCATION AND EXPERIENCE
  • Graduate/Post Graduate in Life Sciences
  • 8+ years' work experience in core monitoring services
  • Certified Research Professionals (preference)


REQUIRED/DESIRED SKILLS
  • Excellent organizational, interpersonal and communication skills (both written and verbal)
  • Ability to supervise multiple projects (low to medium complexity)
  • Demonstrates problem solving skills and critical thinking skills
  • Possesses knowledge of GCP and local country regulatory requirements.
  • Familiarity in MS Word and Excel


CONNECT WITH US!!

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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