Entries tagged with “GCP” from BiotechPharmJobs.com

We at MAKRO deliver custom client-centric solutions by offering contract outsourcing and premium staffing to the most well known IT and Life Science Organizations throughout United States.

Our vision is to become a most reliable "connector" between our clients and the Talent pool i.e "YOU."

Clinical Program Manager
Swiftwater, PA

Description:
• Defines project standards where necessary to ensure consistency across global projects
• Builds effective relationships internally and externally
• Manage information on project performance from all team members (including CROs), alerting the Clinical Team Leader and project team to any potential time slippage.
• Facilitates resolution of problems affecting the achievement of clinical project milestones
• Remain current on trends in individual therapeutic area by attendance at conferences and review of publications

Requirements:
• BSc with 3-5 years' experience in vaccinology / clinical research
• Formal training in GCP methods
• Proven track record in delivering high-quality GCP-compliant Clinical Trials
• International (ie. more than 1 regulatory environment) Clinical Trial experience preferred
• Knowledge of Code of Federal Regulations and regulatory agency documents

To apply, please forward your updated MS Word resume, including availability (if you are authorized to work in the United States for any employer), location and position preferences to glenn.davis@makroscientific.com ******** for review before we speak. or contact our Recruitment Helpdesk at 973-679-5005

Also if you have any friends or colleagues, working on similar skill set, kindly refer them as well as there are multiple open positions.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Manager of BDMP, Quality and Training

Urgent requirement for one of our top clients located in Irvine, CA.

Position Description:
Develops and trains to BDMP SOPs, WIMs, training material and other controlled documents. Applies regulatory ICH, GCP, and ISO quality system requirements to ensure appropriate SOPs, WIMs, and processes are in place and are adequately controlled and implemented within BDMP. Responsibilities are as follows: Participates in the development, training, and maintenance of BDMP controlled documents to ensure global adherence to Good Clinical Practices (GCPs) and related regulations and guidelines. Acts as liaison on teams with other departments, such as Clinical Quality and Training, Clinical Research, RDSIS, WWQA, and Global Regulatory Compliance. Supports ISO-13485:2003 Certification Activities, including complying with WWQA standards, training BDMP, coordinating all preparatory activities within BDMP, participating in the audit and response.

Requirements:

A BS/BA degree, or equivalent experience, in a science, math, or computer science discipline, with an additional 8 years experience in a relevant field; or an MS degree, or equivalent experience, with an additional 6 years experience. A minimum of 4 years of experience directly related to a BDMP-technical area, or 2 years of experience directly related to a BDMP-technical area and 2 years of BDMP or Clinical GCP training experience.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. MBQT_1108, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Senior Manager / Associate Director / Director of GCP Compliance

Urgent requirement for one of our top clients located in Seattle, WA.

Description:
This position will be responsible for managing and maintaining the global GCP compliance program to ensure that clinical development is conducted in conformance with global regulatory requirements. This includes reviewing and auditing clinical operational systems (internal and external) impacted by European EMEA, ICH and US FDA regulations and extensive interaction and cooperation with clinical operations and regulatory functions to create a team approach to the evaluation. This position is also accountable for routine periodic reporting to management regarding audit findings and corrective action progress and the development and management of vendor qualification program including but not limited to pre-approval inspection readiness. This position will also manage GCP auditing staff.

Requirement: Requires BS in Life Sciences or health related field or equivalent and 8+ years of applicable experience required with at least 5 years experience in global GCP compliance auditing in the pharmaceutical industry. At least 2+ years management of audit staff; global management experience is highly desired. Experience in clinical operational or clinical trial management environment is a plus. GCP compliance training experience is required.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest and job No. SMGC_122907, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Clinical QA Auditor

Urgent requirement for one of our top clients located in Brisbane, CA.

Description:
Plans and conducts GCP audits of Company's sponsored clinical trials, CROs, vendors, clinical laboratories, internal processes, databases and clinical study reports, as necessary. Provides assurance that clinical trials are conducted and that data generated and reported are in compliance with protocols, GCP, regulatory requirements through document reviews and audits. Conducts audits to evaluate internal processes related to conduct and reporting of clinical trials to assure compliance with study protocols, SOPs, GCPs, and regulatory requirements. Issues audit reports, recommends corrective action and may conduct follow up to audits and corrective actions. Provides timely written reports to inform management of Company's regulatory status based on audits of CROs, investigator sites and internal audits of Company's processes. May participate in the management of clinical trial product complaint system. Assists in performing GCP training for internal and external customers as needed. Assists in development of Clinical QA Standard Operating procedures, as required.

Requirements:
A BA/BS degree in the sciences, R.N. or equivalent experience. Minimum of 2 years experience in the Biopharmaceutical industry including at least 1 year experience auditing clinical sites and CROs, clinical laboratories, clinical study reports, or internal systems or at least one year experience as CRA. Demonstrates a thorough knowledge of GCP federal regulations and ICH guidelines and other regulations as applicable.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. BD_122707, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.