Get Clinical Research JobsGet Clinical Research Jobs

Clinical Project Manager


Ad
Position Overview:

Provides project leadership in the initiation and execution of domestic and international clinical studies to support both product approvals and market adoption of company products.



Primary Responsibilities:



Write and develop clinical protocols, data and tracking forms, informed consent documents, operating procedures, and associated regulatory filings with investigational sites.

Assists in writing annual and final clinical study reports and clinical sections of regulatory filings.

Tracks data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites.

Works with team to establish study database and edit check requirements.

Serves as liaison between contracted research organizations, clinical trial sites, investigators, study coordinators, physicians, and staff members.

Conducts pre-study site qualification and initiation planning and execution including creation of training materials to ensure compliant study execution.

Assist study sites with IRB/EC submissions and annual reports.

Oversees delivery and shipment of products and equipment required to conduct clinical investigations.

Provides technical assistance to study sites regarding the conduct of clinical research.

Manages clinical sites to optimize the patient recruitment and screening process to reach study recruitment goals.

Perform co-monitoring visits with CRO staff at participating clinical sites

Assists as liaison with Data Management/Biostatistical groups to ensure resolution of data queries.

Monitors clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation.

Creates study Regulatory and Reference Binders as well as internal trial master file to track all study documents.

Review, reconcile and maintain Trial Master Files for multi-center, multi-national clinical trials

Please leave blank
Minimum of 400 (0) characters
Please leave blank
Good news! We have your resume on file, you can use our Quick Apply function to easily apply to this job.

Critical Need Jobs


Employer Information

Previous Page New Search

I appreciate having the opportunity to review the current Pharmaceutical industry positions at the Director of Clinical Research level. There is always at least one position of great interest.

Larry Hofmann, Medical Monitor

Join 3,412 other Clinical Research Professionals receiving FREE weekly job listings to their inbox every week.

We value your privacy. We will not rent your email to anyone.

Browse other Clinical Research Jobs in Massachusetts

  1. Permanent Endocrinology Physician in Boston,...

    Boston, MA
    Endocrinology physician job in Massachusetts : Endocrinologist needed north of Boston100% Endocrine...
  2. Senior Software Engineer

    Boston, MA
    great products for clinical research. * Ability to execute and deliver to tight guidelines and...
  3. Clinical Science Project Manager

    Boston, MA
    regulatory processes and clinical research processes * Self directed - comfortable working in a fast paced...
  4. Clinical Research Scientist

    Newton, MA
    within the assigned clinical development team. The Clinical Research Scientist (CRS) works closely with...
  5. Clinical Research Scientist Immuno-Oncology

    Billerica, MA
    Job Description A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are...
  6. Clinical Research Scientist - perm/direct hire...

    Lexington, MA
    Job Description Title of Position: Clinical Research Scientist (can be Associate Director...
  7. Permanent Endocrinology Physician in Boston,...

    Boston, MA
    Endocrinology physician job in Massachusetts : Endocrinologist needed north of Boston100% Endocrine...
  8. Clinical Data Coordinator

    Boston, MA
    created the industry’s only true end-to-end solution. This one entity combines world-renowned clinical...
  9. Senior Software Engineer

    Boston, MA
    great products for clinical research. * Ability to execute and deliver to tight guidelines and...
  10. Solutions Design Analyst (Requirements Engineer)

    Boston, MA
    levels * Familiarity with FDA regulatory processes, clinical research processes * Self -directed...
Browse all Clinical Research Jobs in Massachusetts
Previous Page New Search