Clinical Affairs Manager

TITLE: Clinical Affairs Manager

LOCATION:  Boston, MA

COMPENSATION: $90K - $120K + Bonus + Stock Options

 

This is a new position, reporting to the VP of Clinical and Regulatory Affairs, in which you?ll build, manage, and staff the clinical function within the company.

 

Our client is a well-funded, privately-held spine technology company committed to advancing patient treatment.  They do this by developing the most innovative products and surgical protocols for minimally invasive spine (MIS) surgery and motion preservation.


Our client operates with the highest level of integrity, both in its personnel and business actions, and in its development activities.  To be considered, you must have a record of impeccable integrity and a strong value system.  If you want to be part of a dynamic and growing organization which promotes teamwork and innovation, then consider joining this team.

 

PRIMARY FUNCTIONS AND RESPONSIBILITIES:

? Develop the strategy and study materials to conduct spinal device clinical studies, including IDE and post-market surveillance studies (primarily US locations)

o  Study protocols, informed consent, case report forms, patient brochures

? Partner with marketing and investigators to develop study strategy

? Collaborate with marketing and sales to select study sites

? Establish scientific methods for study design and implementation

? Build the department?s standard operating procedures with integration of quality system concepts

? Manage clinical studies (including internal and external resources)

o  Manage device shipment and inventory

o  Secure and maintain study site budgets, payments and IRB approvals

o  Coordinate study site monitoring and auditing

o  Establish and manage Clinical Events Committee, as applicable

o  Manage central radiographic reading

o  Manage and analyze data, and write reports

o  Manage investigator meetings

? Collaborate with Manager of Clinical Field Operations to

o  Train clinical site coordinators and clinical site personal on study conduct/regulations

o  Establish metrics to track study site?s progress (e.g., patient enrollment and retention rates, exam compliance, data accuracy)

o  Ensure quality data and study compliance

? Provide reports (interim and final reports) and assist with writing articles

? Collaborate with regulatory affairs and quality assurance, as necessary, to address reported complaints and adverse events

? Collaborate with regulatory affairs on HIPAA and Financial Disclosure requirements

? Collaborate with regulatory affairs on IDE submissions and supplements, as well as PMA submissions

? Hire and manage clinical research staff, as well as contract resources

? Develop the department?s staff through coaching, teaching and formal development activities

? Develop and manage department budget and resources

? Monitor published literature and conduct reviews

? Travel: 25%

 

EXPERIENCE & SKILL REQUIREMENTS:

? BS in life sciences (nursing, medical technology, physician?s assistant); MS, a plus.

? 8 years of clinical research in medical device IDE trials.

? Outstanding communication (written and oral) and organization skills.

? Experience managing people, including setting expectations, monitoring delegated activities and providing recognition for results to develop and encourage professional development.

? Knowledge of medical device regulations, medical terminology, clinical study design, data management and analysis (prior spine or orthopedics experience a plus).

? Ability to read, interpret and develop clinical protocols, associated study materials, professional journal articles and government regulations.

? Strong working knowledge of Microsoft Office.