rovide oversight for the execution of data management activities for multiple programs and manage staff for their assigned programs. Serve as a senior resource to junior staff and consult on business process issues/questions. Lead staff recruitment, onboarding, training and mentoring. Contribute to evaluation of staff performance in-line with the company's performance management process. Lead the development, review and implementation of policies, SOPs and associated documents that impact CDM. Serve as senior Data Management point of contact for submissions and other external regulatory engagements if required (e.g. inspections, RTQs, filing planning)
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met.
- Direct and oversees activities of Data Management staff assigned to studies and tasks within projects
- Perform project level resource management in conjunction with CDM Management
- Lead electronic submission activities for Data Management as appropriate.
- Participate in selecting outsourcing partners for assigned studies including:
- Input to Request for Proposal (RFP)
- Review proposals
- Participate in evaluation/audits and capabilities presentations
- Review project scope of work documentation
- Participate in the evaluation and selection of other third party vendors
- Participate in ongoing monitoring of outsourcing partners and vendors
- Contribute to the development of CDM outsourcing strategies and long term relationships with sourcing partners
- Develop and execute study specific training of staff within a project
- Lead or participate in CDM process improvement initiatives
- Promote and be an advocate for CDM internally and externally
- Facilitate inter/intra department communications
- Develop and manage program level resource plans in collaboration with CDM management
- Addresses Regulatory Submission issues within BCDM and with other related departments.
- Directly supervises employees
- May Indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors.
- BS/BA degree in related discipline and 8 years of related experience; or,
- MS/MA degree in related discipline and 6 years of related experience; or,
- PhD in related discipline and three years of related experience, or;
- Equivalent combination of education and experience.
- May require certification in assigned area.
- Typically requires a minimum of 11 years of related experience and/or combination of experience and education/training.
- A minimum of 9 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
- A minimum of 6 years in a project leadership role
- Experience with Electronic Data Capture (EDC) with Interactive Voice or Web Response Systems (IVRS/IWRS) is required
- Demonstrated experience leading data management teams is required.
- Experience participating in regulatory submissions and inspections is preferred
- A minimum of 5 years of line management experience is required
- 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).
- 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.
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.
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 29 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.