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A BDN client is looking for an eTMF specialist who can provide one year of consulting coverage. This position will have the consultant responsible for the appropriate scan, quality check, file, archival, and retrieval of records for the clinical section of their trial master files (TMF).

A Black Diamond Networks client in Massachusetts is looking for a principal IT architect who can provide one year of consulting coverage. This position will have the consultant leading and managing software implementation projects related to commercial business and systems initiatives.

A Black Diamond client in Indiana is looking for a biostatistician who can provide at least two months of consulting coverage. Our client is specifically looking for an experienced biostatistician who can assist with ongoing clinical studies.

A BDN client in Texas is looking for a regulatory affairs specialist who can provide six months of consulting coverage. Our client is looking to hire a senior level consultant to help assist with multiple types of regulatory submissions for class I - III medical devices. The types of submissions include TMF, US dossiers, EU dossiers, and 510ks.

A BDN client is looking for a strong GCP auditor who can perform a series of vendor audits for companies providing clinical trial assistance for site audits throughout 2019. These vendor audits will consist of the qualification of new vendors as well as routine audits of existing vendors. The site audits will be GCP audits of various clinical trial and investigator sites.

A Black Diamond Networks client in Massachusetts is looking for a contract medical director who can provide at least one year of consulting coverage. This position will have the consultant working as a strategic, cross-functional, partner providing expert medical and scientific input for the development of MDR-related tasks.

A BDN client in Massachusetts needs an MDR manager who can provide at least 12 months of consulting coverage. This position will have the consultant serving as the subject matter advisor for all things relative to our client's EU MDR program. The consultant's responsibilities on the job will be to review the content of internal product documentation and regulatory submissions for both new products and renewals.

The client is looking for an experienced project manager that has managed drug development projects across cross-functional teams and is highly skilled at leading and driving projects and project teams. The client has numerous drug development projects that are typically assigned to an SME or technical lead and often the SME needs project management assistant to plan out the project for clinical development, regulatory pathway, process development, CMC, etc.

A BDN client in Illinois is looking for a medical writer who can provide one year of full-time contract coverage. Our client is looking for a candidate with at least five years of experience who can write clinical protocols, clinical study reports, investigatory brochures, and other clinical documents in conjunction with their project team.

A BDN client in Massachusetts is searching for a contract process engineer who can provide at least one year of coverage. Our client is looking for strong candidates who have at least 10 years of experience working with processing equipment (Disco dicers, pick and place equipment, thermocompression bonding equipment, etc.), semiconductors, process development, and lean methodologies.