Clinical Project Manager (Generics)Clinical Project Manager (Generics)
Location: AL - Huntsville
Position ID: Q1-4
Description
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics Inc., and Qualitest, please .
To support our critical business strategies, we are currently seeking aClinical Project Managerto join our Generics Development team. This role will be located at our Huntsville, AL Generics facility.
The Clinical Project Manager (Generics), will plan, implement, manage, and report on Bioavailability and Bioequivalence (BA/BE) studies for Endo generic products. Coordinate with the Clinical Research Organization (CRO) for the development, planning, execution, and monitoring of the Bioequivalence studies program for Huntsville site. Monitor bioequivalence studies and ensure that assigned studies are conducted according to GCPs, ICH guidelines.
The key responsibilities will be to:
Manage all activities for Bioavailability and Bioequivalence for Endo products
* Manage all efforts to ensure clinical project goals are achieved according to project team expectation. Work with the project team to meet assigned goals.
* Work closely under the guidance of Clinical Projects Director to develop and implement specific study plans and ensure that appropriate resources are available for the project.
* Contributes to the review and/or design of study protocols for bioequivalence studies.
* Planning, execution, timelines, budgets, resources and overall direction of one or more clinical programs in accordance with organizational SOPs, policies and GCP/ICH guidelines under the direction of a Clinical Project Director.
* Periodic reporting the updates to Clinical Project Director.
Manage the efforts of key functional department
* Perform project related activities according to project milestones, timelines, and processes
* Maintain current knowledge of trends, agency guidance to participate and resolve concerns about the studies.
* Provide advice on feasibility and scientific aspects of study design
* Assure clinical data protocol objectives and bioavailability requirements are met.
Manage agreements with the CROs and other vendors.
* Assist in the evaluation, selection, contracting, and management of CROs and ensures adherence to overall study budgets and timelines.
* Evaluate capability, qualification, service experience and fit with company needs·
* Assure contract requirements meet strategy, corporate and legal requirements and corporate business service models
* Plan availability of Clinical Trial Material (CTM) and coordinate the process for preparation of the CTM labelling and shipment to the clinical site.
Perform on-site monitoring of clinical studies
* Review records to ensure bioequivalence studies are conducted in compliance with currently approved protocols, applicable regulations, work instructions, guidelines, and or policies.
* Ensure compliance with all human subject protection and privacy regulations, including review of Informed Consent Materials. Assure that the regulatory documents are reviewed and tracked throughout the study.
* Ensures site compliance with the clinical study protocol, documentation, and resolution of monitoring issues, safety, investigational product accountability, and preventative/corrective action plan.
Manage review and/or edit of study documentation
* Review the bioequivalence reports required for the ANDA submission in eCTD format.
To qualify for this role, you will possess:
* Minimum BS degree in biology, allied health or related life science with 10 years working in clinical research performing bioavailability and bioequivalence studies in the generic pharmaceutical industry or MS degree with 5 years experience as stated above or PhD/PharmD degree with 3 years experience as stated above.
* Experience being responsible for developing strategies for Bioavailability/Bioequivalence studies for generic products.
* Knowledge ofin-vitro-in-vivoco-relation including interpretation of pharmacokinetic data.
* Strong interpersonal, presentation, writing and communication skills.
* Must have strong knowledge of scientific study design and data analysis.
* Capable of managing multiple clinical trials.
* Strong computer skills with working knowledge of software packages (e.g., MS Word, MS Excel, MS Project).
Endo Pharmaceuticals recognizes the advantages of a diverse workforce through its commitment to equal employment opportunities.
|
