Director - Clinical Research

Location
FRISCO, TX, USA
Salary
Competitive
Posted
Dec 06, 2017
Closes
Jan 06, 2018
Ref
293993196
Discipline
Medicine
Contract Type
Full Time
Title: Director - Clinical Research
Location: United States-Texas-Frisco
Job Number: 00001MOJ

POSITION SUMMARY:
Under general oversight of the Senior Vice President, IntrinsiQ Specialty Solutions, this position is tasked with the overall management of the clinical research network.
PRIMARY DUTIES AND RESPONSIBILITIES:
Accountable for the development and management of the AdvanceIQ Network, our clinical research network:

Directs the daily operations of all AdvanceIQ Network staff to secure successful achievement of annual and long term goals and objectives for the department
Provides direct oversight for the ongoing assessment of infrastructure needs to ensure delivery of the AdvanceIQ Network to participating practices and the life sciences industry including pharmaceutical companies, simultaneously maintaining fiscal responsibility
Directs the development, coordination and execution of the operational plans the AdvanceIQ Network, ensuring that practices have implemented the appropriate research standards per the federal regulations
Oversees the delivery of services to network practices and the pharmaceutical industry according to timelines
Responsible for all marketing and selling activities for the AdvanceIQ Network
Works with the Clinical Research team to establish/maintain and execute on key activities associated with the Research Advisory Board(RAB)
Direct management and supervisory responsibilities for the clinical research team
Maintains fiscal responsibility of AdvanceIQ Network:

Develops and negotiates sponsor study/trial budgets in conjunction with Senior Manager, AdvanceIQ Network,
Develops the annual budget projections the AdvanceIQ Network and works with senior executives and finance to finalize
Accountable for the AdvanceIQ Network's attainment of annual fiscal budget projections
Manages overall budgeting activity, both annual and long term for AdvanceIQ Network
Work with Senior Manager, AdvanceIQ Network, on negotiating practice budgets to ensure that the practice research site's cost are covered as part of the study sponsor's budget or paid by the practice for incremental services needed to support research growth within their practices
Maintains the format and methodology for securing long term research contracts
Establishes/maintains clinical relationships with the key pharmaceutical companies and strategic partners, including clinical research organizations:

Responsible for business development activities to secure additional industry contracts by reviewing and assessing all trial opportunities/proposals
Responsible for maintaining the knowledge base of pharmaceutical pipeline drugs that would benefit the overall network by participating in clinical trials, patient registries, prospective observational studies, and other outcomes/economics-based research.
Responsible for presenting AdvanceIQ Network capabilities and performance history to potential life sciences medical affairs departments to secure long term relationships
Represents AdvanceIQ Network at research related professional meetings to enhance network visibility
Fosters pharmaceutical relationships, prioritizing pharmaceutical companies with strategic specialty drug, diagnostics and device pipelines
Supportive Responsibilities:

Manages weekly management calls with Sr. Manger, AdvanceIQ Network and Sr. Vice President, IntrinsiQ Specialty Solutions
Manages scheduling of meetings/presentations to industry
Responsible for communication between AdvanceIQ Network and ABC executives as appropriate
Interacts with network practices when requested by other AdvanceIQ Network or business unit staff
Responsible for all administrative duties in support of this position
Other Duties:

Travel requirements: investigator meetings, industry meetings, ION meetings as needed
Attends study related teleconferences and meetings, as required
Fosters collaborative working relationships with co-workers, practices, and physicians
Abides by the Code of Federal Regulations referring to GCP and ICH guidelines at all times
Performs related duties as assigned. Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
Must possess Bachelor's Degree (BA, BS) required/Medical, Nursing or Science background highly desired; Business background desired; ten (10) years of clinical research experience, eight (8) years of clinical trial experience, six (6) years of supervisory and personnel management experience desired.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Detail oriented
Self motivated, team-oriented
Ability to work with minimal supervision and in a home environment
Must have experience working/interacting with medical professionals, both clinically and within the pharmaceutical industry
Critical operations review experience required
Demonstrates in-depth knowledge of clinical study processes regarding problem identification and generation of solutions required
Demonstrated knowledge of federal regulations, ICH Guidelines, GCPs and ION-CR SOPs pertaining to the conduct of clinical trials
Strong leadership skills
Strong organizational, communication and negotiation skills
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