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Job Details

Clinical Project Manager

Company: ClinTec International Ltd
Location:
Reference: US-PM-110816-DH
Closing Date: 28 Dec 16
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

ClinTec International is actively recruiting for a Clinical Project Manager to join our expanding global company in the US – this is a Permanent Office based opportunity. By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Requirements:

Clinical Project Manager – Cambridge, MA – Permanent or Freelance contract

ClinTec International is actively recruiting for a Clinical Project Manager to join our expanding global company in the US – this is a Permanent Office based opportunity. By working for ClinTec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits. 

Role Description

The Clinical Project Manager, is responsible for orchestrating clinical operational activities across a compound that is under development. This role will oversee one or more indications within a single compound. The company is focused on indications related to anemia, oncology, and vascular development. Each indication will be developed in clinical studies performed on a global scale in coordination with international Clinical Research Organizations. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the Director of Clinical Operations..

Responsibilities of the Clinical PM:

Provide oversight of clinical operations team functioning in study management roles.
Track current clinical operations staff utilization to gauge adequate resources and monitor performance metrics.
Arrange for the orientation and training of new clinical operations staff in accordance with SOPS.
Provide management with routine updates regarding the status of ongoing studies.
Proactive issue resolution.
Ensure operational activities across studies and indications are managed using consistency where possible.
Participate in protocol review to ensure seamless integration between clinical objectives and study performance.
Establish working relationship with clinical and internal and external medical experts to optimize and implement clinical studies.
Participate in CRO review, selection, and negotiation for each study.
Ensures team has strong oversight of CROs in all aspects of study implementation and that documentation is appropriate.
Participate in review of all supporting documents for a clinical study – Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.
Joint responsibility with clinical and monitoring manager to ensure resourcing needs and issue resolution are adequate.
Develops and maintains relationships with external vendors.
Collaborates with consultants and contractors to Research and Development.
Participate in the development and implementation of clinical operations standard operating procedures and common work practices within the team.

Essential Criteria:

Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable) with at least 5-7 years of experience in clinical research operations.
Experience in running one or more clinical studies (Phase 2 and/or 3) in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology.
Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
Demonstrated experience in study management/monitoring and data management, working with, and negotiating with Clinical Research Organizations (CROs).
Demonstrated project management expertise, including the leadership and development of cross functional teams.
Demonstrated ability to work independently with exceptional organization and attention to detail.
Excellent oral and written communication and presentation skills.
Office based in Cambridge, Massachusetts, United States

Desirable Criteria:

Formal Project Management Training / Accreditation 

Company Information:

ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organization with a presence in over 43 countries worldwide.  We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries for over a decade and assist in their key product development efforts. At ClinTec International, we pride ourselves on delivering high quality, flexible and professional services/solutions for our clients.  ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

ClinTec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process.  We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects - with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.

Apply for this job: Clinical Project Manager

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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