Thursday 22 September 2011

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The International Partnership for Microbicides, Inc. (IPM) is a non-profit product development partnership (PDP) established in 2002 to prevent HIV transmission by accelerating the development and availability of a safe and effective microbicide for use by women in developing countries.

IPM is committed to providing women with an affordable and self-initiated HIV-prevention strategy to reduce the cycle of infection which has led to the deaths of more than 25 million people worldwide and orphaned more than 15 million children since 1981. Like the promise of a future AIDS vaccine, microbicides represent an essential component of an integrated and comprehensive global response to the HIV/AIDS epidemic.

We offer the following positions in our IPM, South Africa branch, located in Paarl:

I. PROJECT MANAGER(S)
The Project Manager (PM) is primarily responsible for managing and co-ordinating all project activities associated with Phase I, II and III clinical studies.

Requirements:
• Bachelors degree in life science or healthcare field, or equivalent; • Minimum three (3) years’ experience in clinical research; • End-user computer efficiency, with proficiency in Microsoft Office products; • Willingness and ability to travel as required (typically requires 0-30% travel); • Ability to motivate and mentor, and maintain positive interpersonal relationships; • Familiarity with HIV/AIDS and/or Africa/Asia medical settings is desirable.

Key Performance Areas:
• The design, planning, implementation, conduct, and reporting of Phase I, II and/or III clinical research projects; • Providing training, review reports and assists with mentoring of Clinical Associates and Clinical Research Associates; • Excellent verbal and written skills; must be able to communicate effectively at all levels of the organisation; • Good conflict resolution and problem solving skills;
• The oversight of external partner-collaborators and vendors in order to achieve product development goals. • Ability to work independently and in a cross-functional team environment

II. CLINICAL RESEARCH ASSOCIATE(S)
The Clinical Research Associate (CRA) is responsible for managing and co-ordinating project activities associated with the monitoring of Phase I, II and III clinical studies.

Requirements:
• Bachelors degree in life science or healthcare field, or equivalent; • Minimum one (1) year experience for CRA in clinical research; • Willingness and ability to travel domestic and internationally as required (up to 60% travel); • End-user computer efficiency, with proficiency in Microsoft Office products; • Valid driver’s licence; • Ability to motivate and mentor, and maintain positive interpersonal relationships; • Familiarity with HIV/AIDS and/or Africa/Asia medical settings is desirable. • Highly motivated, team oriented and organised; • Must be able to communicate effectively; • Good conflict resolution and problem solving skills.

Key Performance Areas:
• Development and review of any Phase I, II and III clinical study related documentation; • Conduct pre-study, initiation, monitoring and close-out visits; • Reporting and following up of safety events; • Ensures adherence to protocol and GCP; • Oversight of the quality of the clinical data including resolution of queries and development of study reports; • Assisting in preparation of Regulatory and/or IRBs/IECs; • Preparation and tracking of investigator financial documentation and payments; • Providing training, review reports and assists with mentoring of Clinical Associates.

III. CLINICAL ASSOCIATE
The Clinical Associate is a training position to become an independent Clinical Research Associate. Therefore, provides support across clinical programs, and assists in the implementation and conduct of study protocols at research sites. The CA will be working under close supervision and mentoring of a more senior Clinical department staff member.

Requirements:
• Bachelors degree in life sciences; • Willingness and ability to travel domestic and internationally as required (up to 60% ravel); • End-user computer efficiency, with proficiency in Microsoft Office products; • Highly motivated, team oriented and organised, • Must be able to communicate effectively, work independently in a cross-functional team environment and have good conflict resolution and problem solving skills.

Key Performance Areas to be developed during the 6-month training period to become a CRA:
• Development and review of any Phase I, II and III clinical study related documentation; • Conduct pre-study, initiation, monitoring and close-out visits; • Reporting and following up of safety events; • Ensures adherence to protocol and GCP; • Oversight of the quality of the clinical data including resolution of queries and development of study reports; • Assisting in preparation of Regulatory and/or IRBs/IECs; • Preparation and tracking of investigator financial documentation and payments; • Any clinical research related topics.

IV. CLINICAL TRIALS ASSISTANT(S)
The Clinical Trials Assistant (CTA) will work closely with the project team to provide assistance with project start up, maintenance, close-out and tracking of study documents.

Requirements:
• Associate's degree in life science or healthcare field, or equivalent; • Minimum one (1) year project administrative experience, or equivalent; • End-user computer efficiency, with proficiency in Microsoft Office products; • Highly motivated, team oriented and organised; • Must be able to communicate effectively; • Good conflict resolution and problem solving skills.

Key Performance Areas:
• Performing any general administrative and clerical duties for project team, as directed. • Organising project team meetings both internally and externally (i.e. preparing agenda and meeting minutes); • Assisting in review and preparation of study documentations; • Preparation and assistance with study related correspondence to/from sites; • Tracking of study related information;

V. MEDICAL MONITOR
The Medical Monitor is primarily responsible for medical management of adverse events and medical oversight of safety projects to ensure that company SOPs and regulatory requirements are consistently followed.

Requirements:
• MBChB or equivalent; • Minimum 2 years’ experience as a Medical Doctor; • Clinical experience/knowledge of HIV/AIDS; • Knowledge of FD&C Law, 21CFR, and FDA safety guidelines and guidance documents preferred but not required; • Knowledge of various ICH safety reporting requirements and CIOMS Working Groups reports preferred but not required; • Working knowledge of biostatistics, and data management; • Ability to simultaneously handle multiple complex issues for multiple projects and/or clients; • Ability to work both as a "team player" with a high degree of independence; • Ability to work with a high degree of independence in decision-making and problem-solving; • Strong attention to detail; • Effective analytical and problem-solving skills, using creativity and judgment in resolving issues; • Good writing and critiquing skills for preparing, reviewing and critiquing reports; • Excellent written and oral communication skills.

Key Performance Areas:
• Medical management of clinical research programs i.e. investigator brochure; protocol development; adverse events • Medical oversight of safety projects to ensure that company SOPs and regulatory requirements are consistently followed; • Medical review of safety reports and associated QA documentation; • Compilation and preparation of periodic safety reports to Regulatory Authorities/IEC(IRB); • Therapeutic training to clinical team, as needed.

VI. STATISTICIAN/ BIOMETRICIAN
The Statistician/Biometrician will provide statistical and data management input into the microbicide development process.

Requirements:
• Master's degree in statistics; • At least three years of pharmaceutical industry experience; • Ability to apply a broad range of statistical techniques in support of clinical research studies; • Excellent writing and speaking skills and the ability to explain and defend statistical strategies to others; • Good working knowledge of clinical trial methodologies and regulatory guidelines for drug/vaccine approval; • Knowledge of SAS programming and other statistical software

Requirements:
• Input in general study design and analysis; • Strategic planning, development and oversight of data management processes; • Statistical assessment of safety, efficacy, compliance, and acceptability results from phase I/II and III human clinical trials; • Good working knowledge of data collection methods and databases used to support clinical trials.

To Apply - Closing date: Tuesday 28 November 2006. All applications must include at least two recent references, contactable by phone.

This job description should not be construed to imply that these requirements are the only standards for the position. Other duties will be assigned. IPM has the right to revise this job description at any time. IPM is an "at will" employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and IPM.

Qualified candidates should submit a cover letter, curriculum vitae, and salary requirements by email to careers@ipm-microbicides.org or by fax to +27 (0)21 872 5266 or by mail to PO Box 3460, Paarl, 7620.

Visit our website at www.ipm-microbicides.org. The International Partnership for Microbicides, Inc. is an Equal Opportunity Employer.

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