Associate Director, Clinical Data Management

SUMMARY/JOB PURPOSE:

Oversees, develops and manages clinical data management activities while collaborating and coordinating with other departments. Oversees the evaluation, integration and implementation of new clinical systems and technologies for clinical trial management activities including electronic data capture and documentation systems.

Essential Duties And Responsibilities:

* Provides a high level of expertise in data management to support clinical studies, including areas such as: Case Report Form (CRF) design, database design, data management plans, edit checks/quality review plans, query resolution processes, data transfers, SAE/AE reconciliation, thesaurus coding processes, and database lock.
* Manages time and resource constraints across multiple projects.
* Develops and implement new or improved processes for data management.
* Effectively manages Clinical Research Organizations (CROs) to ensure high-quality deliverables within timeline and budget.
* Participates in development of Request For Proposals (RFPs) and evaluation of vendors, products and proposals.
* Provides oversight on quality and timeliness of task completion by direct reports.
* Develops and implement training curriculum for data management activities and principles as required.

Supervisory Responsibilities:

* Directly supervises employees
* May Indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

* BS/BA degree in related discipline and a minimum of 11 years of related experience; or,
* MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
* PhD in related discipline and a minimum of 5 years of related experience, or;
* Equivalent combination of education and experience.
* May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

* Typically requires a minimum of 14 years of related experience or the equivalent combination of experience and education/training.
* Experience in Biotech/Pharmaceutical industry preferred.
* Demonstrated experience leading data management teams is required.
* Experience participating in regulatory submissions and inspections is required
* A minimum of 7 years of line management experience is required

Knowledge/Skills:

* Has extensive experience in relevant industry/profession.
* Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
* Develops technical and/or business solutions to complex problems.
* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
* Guides the successful completion of major programs, projects and/or functions.
* Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
* Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
* Has complete understanding and wide application of technical principles, theories, concepts and techniques.
* Has extensive knowledge of other related disciplines.
* Applies strong analytical and business communication skills.
* Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.
* Knowledge of Good Clinical Practices (GCP) is essential.
* Demonstrated success managing data management activities of Clinical Research Organizations (CROs).

JOB COMPLEXITY:

* Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
* If in a leadership role, works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
* Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
* If in a leadership role, participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
* Ensures budgets and schedules meet corporate requirements.
* Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.