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Clinical Operations Consultant
at HireResources
Jersey City, NJ

Clinical Operations Consultant
at HireResources
Jersey City, NJ

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Description

Job Description

 

Title:

Clinical Operations Consultant (COTL)

Department:

Clinical Development (CLN)/Clinical Technical Operations (CTO)

Supervisor:

Sr.Director of Clinical Development

POSITION OVERVIEW/SUMMARY

Working with closely with the Sr. Director Clinical Operations and the Development Team Leader(s), the Senior Director, Clinical Operations directs global clinical operational activities for, guiding activities and influencing colleagues in a highly matrixed environment. The incumbent will manage activities related to executing clinical studies in support of development programs in accordance with company SOPs, FDA, & ICH guidelines and regulations.

 

The Clinical Operations Consultant (COTL) will lead the operational strategy for trial execution, implementation, monitoring, analysis, data delivery and regulatory submission.  He/she will lead the successful execution and timelines for clinical trials drawing on a high level of expertise with clinical and regulatory requirements, both local and international, for clinical operational processes and requirements.

KEY RESPONSIBILITIES

§ Lead overall operations program/team responsible for execution of global clinical trials; oversee individuals managing operational execution of global clinical protocols for MTDA.

§ Provide clinical trial oversight and management, vendor and CRO performance (including bid/contract, budget/adjudication) and regulatory quality delivery of clinical trials according to corporate processes and timelines.

§ Work collaboratively with internal and external staff associated with clinical operations as well as CROs and vendors associated with operational functions.

§ Recommend and/or assess potential CROs and vendors in collaboration with Sourcing and other colleagues.

§ Lead data review and discrepancy resolution, team meetings/presentations for a clinical trial with senior management, in the US, EU and Japan, as needed.

§ Define and present complex operational objectives as required for senior management.   

§ Oversee data collection activities for clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, NDA etc.  

 

RELATIONSHIPS

Reporting:

§ Reports to Sr. Dir Clinical Dev (CTO)

Managerial:

§ Guides and mentors colleagues and indirect reports in a complex matrixed environment while overseeing a global clinical trials.

Other:

§ Works cross-functionally and collaboratively with Project Management, Medical, Regulatory, Commercial, R&D and other key business areas in the U.S. and globally.

 

QUALIFICATIONS 

Education:

§ BS or higher level degree.

§ Strong ability to build peer relationships and communicate effectively with company disciplines, cross-functional, and external teams.

 

Professional Experience:

§ 10+ years of increasing responsibility in clinical operations in a pharmaceutical company or CRO with a strong background in clinical trial design.  

§ Successful experience in a large pharmaceutical company and complex matrix-based organization.

§ Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA).

Knowledge and Skills:

§ Expertise in clinical and regulatory requirements, both local and international, of the clinical medicine and drug development processes.

§ Expertise in outsourcing and CRO management; outstanding budget oversight and adjudication skills.

§ Highly analytical, scientific mind with exceptional problem-solving skills.

§ Confident operations leader with proven ability to apply knowledge base to effectively manage, mentor and motivate staff in a matrix environment to achieve corporate objectives.

§ Superior interpersonal skills coupled with multicultural awareness. Able to successfully establish relationships, communicate effectively within/across company disciplines and thrive within a global, highly matrixed organization.

§ Skilled at leading external teams at remote locations.

§ Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials with short timelines in a fast-paced setting.

§ Attention to detail and commitment to high quality and on-time deliverables.

§ Outstanding computer skills including MS Office.

§ Willingness to travel domestically and internationally.

 

Company Description

HireResources recruiters are not generalists; they are specialists in their industries providing quick access to industry top talent in select industry sectors. We speak your language and understand the factors critical to your business. Each HireResources Sector Team has a specialized target recruitment function. In fact, if we do not have expertise in your industry, we will let you know this up front.

HireResources was established in 2002, in 2015 we began a growth phase by restructuring our core business, today, HireResources is a fast growing Staffing & Recruitment platform headquartered in Connecticut. HireResources is an open source staffing and recruiting model giving flexibility and support to top executive recruiters across the country. HireResources recruiters are thoroughly vetted and are proven professionals in the recruiting industry.

The cornerstone of HireResources success is in its commitment to ethical business practices and superb consumer service. Our "Code of Ethics"​ is the foundation of this success.

Integrity - Work honestly, every day.
People - Develop and deliver diverse talent
Customer Focus - Anticipate priorities & exceed their expectations
Respect - Value all customers and collaborate with one another
Performance - Be accountable, manage risks and deliver a high level of quality.

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