Business Development Manager

IQVAMED Gives You Opportunity to Become Experienced.

Business Development Manager

 Identify new sites, PIs and Assists in evaluating new protocols for feasibility at the site.
 To coordinate with Principal Investigator, Institutional Review Board/ Institutional Ethics Committee, Sponsor/CRO & Team for conduct of the clinical research/trials.
 Reviewing the protocol/synopsis and other materials, such as NDA, feasibility questionnaire and Approached to PIs as per study indication for further process discussion.
 Assessing the ability to meet the study timelines in light of other site commitments and overall feasibility
 Looking at subject eligibility requirements and determining if those subjects would be available in the practice.
 Assessing the resources necessary to do the study, including people, physical space, etc.
 Collecting curriculum Vitae, MRC, and GCP Certificate of Principal Investigator, sub- Investigator and other study professionals, and send along with completed Site feasibility questionnaire.
 Assessing for Site Selection Visit (SSV) & Site Initiation Visit (SIV).
 To conduct the clinical trial according to ICH-GCP guidelines, New drugs and Clinical trials rules 2019, and other applicable regulatory guidelines.
 To systematize processes in order to attend high level of standards during research process.
 Preparing documents for submission to the Institutional Review Board (IRB)/ IEC
 Attending the Investigator meeting, as appropriate, and train staff about their duties related to the ongoing clinical trial.
 To obtain and document the Informed Consent form which should comply with the applicable regulatory requirements and adherence to GCP and to the ethical principles that have their origin in the declaration of Helsinki.
 Presenting the informed consent form to potential subject, discussing the consent and the study with them and answering questions.
 Obtaining subject’s signatures on the informed consent forms, and ensuring that all necessary signature and dates are on the ICF.
 Documenting, distributing and filing assigned informed consent forms appropriately.
 Ensuring that all amended consent forms are appropriately implemented and signed.
 To ensure that neither the investigator nor the trial staff, should coerce or unduly influence a subject to participate or to continue participate in the trial.
 To ensure that the rights and well-being of the subjects are protected.
 To provide patient Information sheet to the subject.
 Contacting and screening potential subjects for the study.
 Recruiting Subjects, Scheduling Subject and Sponsor Visits.
 Preparing for each subject visit to ensure that all appropriate study procedures are done.
 Assisting the Investigator with study subject visits.
 Ensuring that All necessary data are gathered and recorded in the appropriate source documents (i.e., Patient charts) and the case reports forms.
 Reviewing case report forms entries for completeness, correctness and logical sense in addition, review the source documents and case report orms for adverse events that may have been missed.
 Working with sponsor monitors (CRAs) during monitoring visits.
 Making corrections to the case report forms, if appropriate and resolving data queries.
 Managing laboratory procedures (drawing samples, Processing, packaging and shipping).
 Preparing Invoices and managing payments to study subjects, if appropriate.

 Preparing Invoices and managing payments to study subjects, if appropriate.

IQVAMED

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Clinical Research Services

Pharmacovigilance Services

Patient & Healthcare Services

IQVAMED Gives You Opportunity to Become Experienced.

Business Development Manager

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