General Manager Research Regulatory Specialist (RRS)

Aug 31, 2018

Job Description

An exciting new job opportunity has opened for a suitable candidate to develop, implement and deliver top-notch managerial relationship and attitude for African Clinical Research Limited. A passion for technology and project delivery focused is required.

Job Responsibilities

Oversees day-to-day business operations
Provides leadership to all levels of the organization
Communicates and embody the company’s vision and values
Builds up the company by interviewing, hiring, and mentoring new talent
Defines and implement policies and performance standards
Evaluates employee performance and provide additional coaching and support as needed
Assesses departmental and company performance and devises plans for improvement
Manages profit and loss statements and accounts for costs and revenues
Allocates budget resources for supplies, equipment, marketing, and personnel
Supports clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial’s duration for research studies involving human subjects.
Establishes and maintains processes and also monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies, procedures, and regulations.
Manages identified issues and provides feedback to leadership regarding resolution.
Disseminates information and participates in training.
Provides direction and feedback to the research team to ensure awareness of business practices and quality standards.
Documents any exceptions to compliance standards.
Manages new submissions and continuing review activities.
Reviews initial submissions to determine the review category and action to be taken.
Completes submission applications, and other required documentation prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
Completes protocol renewal applications, amends applications and maintains the record of all adverse event reports.
Attends research team meetings and reports on regulatory issues.
Responsible for administrative duties corresponding to budgets and contracts.
Performs related responsibilities as required.

Job Requirements Education:

B. Pharm/MBBS. MBA preferred.

Knowledge, Skills & Experience:

Market knowledge
English language fluency
Oral, written & presentation skills
Ability to build strong relationships
General sales skills, including need identification, questioning, listening, negotiation and closing.
Strategy development skills
Motivated, dynamic & industrious with “can-do” attitude.
Personable & professional appearance
Good commercial acumen.
Past managerial experience required.

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Use the link(s) below to apply on company website.  

https://www.myjobmag.com/readjob/56751/jobs/job-openings-at-african-clinical-research-limited-acr