Director, Head of Data Management

Job Description:
The Director, Head of Data Management is a position responsible for providing expertise and leadership of the clinical data management function which enables planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data. This role will oversee all Clinical Data Management (CDM) preparation to meet corporate goals, budgets, and timelines. This includes but is not limited to vendor qualification/selection, budget planning and contract negotiations, development of corporate data standards, and oversight of all CDM services from study start-up through database lock and study close-out. The Director, Head of Data Management will be accountable for the assessment of resource needs both internally, as business needs dictate and with CRO partners.Essential Duties and Responsibilities:

Partner with Clinical Development and Biostatistics to ensure the highest quality planning for data collection, data cleaning and data display for all clinical studies and submission documents.
Provide leadership and oversight of data management on Program Development teams, with a focus on delivering high quality, reliable clinical trial information to support the execution of clinical programs across all phases of development.
Accountable for ensuring data is handled consistently from startup through database lock - communicates timelines, resource needs, priorities and other information vital to the efficient conduct of the development programs.
Central point of contact for data related deliverables, issues, challenges, risks and mitigations for a program(s) or asset.
Lead and develop the data management relationship with preferred providers.
Keeps current on DM standard practices, competitive environment, regulatory or scientific trends, as well as general industry standards and regulatory requirements pertinent to CDM responsibilities.
Leads the development of global standards and processes including standardized case report forms and CRF instructions, Data Management Plans, and data review documents.
Lead CDM standardization initiatives.
Responsible for enhancement of CDM infrastructure, capacity and efficiency, especially in EDC study-build, MedDRA and WHOdrug coding, etc.
Develop, lead and collaborate on key initiatives related to data monitoring such as Risk Based Monitoring implementation.
Responsible for ensuring program budgets associated with clinical study CDM activities are managed within company thresholds.
Develop and maintain SOPs pertinent to CDM responsibilities and collaborate on development of global CDM SOPs.
Performs other related duties as assigned by management.


Required Qualifications

Bachelor's degree in life sciences or equivalent required
Minimum of 10 years industry experience.
Experience in people management, resource assessments and scaling teams, as business needs dictate.
Knowledge of transplant/autoimmunity research standards and best practice in data collection methodology and operational approaches preferred.
Extensive global clinical trial expertise and a successful track record of leading through influence and working across global organizational environment
Experience working in collaboration with CROs
Knowledge of FDA and ICH GCP guidelines, standard concepts, practices, and procedures relevant to clinical DM
Experience in regulatory GCP inspections/audits
Experience with data visualization software
Knowledge of standard coding dictionaries MedDRA, WHOdrug, etc and related best practices.
Expert knowledge of industry eCRF tools, specifically Veeva and Medidata RAVE and familiar with industry trends and technologies supporting data collection
Cross functional collaboration proficiency with other departments such as Biostatistics, Statistical Programming, Clinical Operations and Pharmacovigilance
Solid PC skills including Data Management software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized at client).
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret abstract and concrete concepts.


Preferred Qualifications:

Master’s degree in Life Sciences
Experience in start-up / scale up companies
Experience building out functions / departments


Competencies

Ethics - Treats people with respect; Shows respect and sensitivity for cultural differences; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values; Promotes a harassment-free environment.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
Change Management [not to be confused with QMS] - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self-available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
Visionary Leadership - Displays passion and optimism; Inspires respect and trust; Mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.