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Study Director/Study Manager

Company: MEDPHARM LTD
Location: Durham
Posted on: September 17, 2020

Job Description:

MedPharm Ltd is an innovation-driven pharmaceutical development company committed to the identification, creation and development of unique therapeutic systems for topical use, specializing in drug delivery. Over the past 3 years, MedPharm has continued to expand their operations in their RTP facilities.

We are looking for a talented and detail oriented Study Director/ Study Manager to join our growing team. As a Study Manager, you will work with our senior staff, project managers, and lab personnel to ensure accurate study project transition. The successful candidate will strive to attain in-depth knowledge of MedPharm procedures and understand the importance of project activity and movement.

In addition to having strong attention to detail, you must be responsible and demonstrate excellent communication skills. If you thrive in fast-paced working environments that require a professional with drive and exceptional analytical skills, then you could be our ideal candidate.

Responsibilities:

To draft study plans and contribute to the preparation of reports for sponsors.

For any studies performed according to GLP, assure that: The study protocol (plan), including any change, is approved and is followed.

All experimental data including observations of unanticipated responses of the test system are accurately recorded and verified.

Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.

Test systems are as specified in the study protocol (plan).

GLP regulations are followed where appropriate.

All raw data, documentation, protocols, specimens and final reports are transferred to the archives during or at the close of the study.

To provide support in study/project transition from development to GMP supplies in line with applicable regulations.

To adhere to MedPharm’s Procedures.

Contribute to the preparation and review of SOPs and Forms where applicable.

Assist Project Managers as technical experts on client correspondence.

Where applicable, promptly record all data according to Good Documentation Practices.

Review literature in preparation for studies and to regularly update knowledge by reviewing appropriate literature.

Requirements:

BS Degree in Biology, Chemistry, or a related field ; or equivalent with experience

1-5 year's experience in pharmaceutical development, ideally in topicals but a different dosage for area may also be beneficial.

Excellent communication skills with a collaborative style of working as the position will have key relationships across different internal teams as well as with clients.

Detail oriented and meticulous.

Strong attention to detail with an analytical and methodical approach to tasks.

Ability to work to deadlines and targets.

Ability to adhere to MedPharm’s company ethos

Must be motivated by a small company environment.

Able to work professionally and productively under pressure.

High degree of personal credibility and integrity.

Bonus:

Experience with Good Laboratory Practices

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Keywords: MEDPHARM LTD, Durham , Study Director/Study Manager, Other , Durham, North Carolina

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