Director, Head of Data Management

The Director, Head of Data Management is a key position at Planet Pharma, responsible for providing expertise and leadership of the clinical data management function. This role enables the planning, coordination, and timely delivery of complete, high-quality, and reliable clinical trial data.

This position oversees all Clinical Data Management (CDM) preparation to meet corporate goals, budgets, and timelines. This includes 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 and with CRO partners.

• 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 WHO drug 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 the development of global CDM SOPs.
• Performs other related duties as assigned by management.

• 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 practices 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 environments.
• 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, WHO drug, 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.

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

• 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 - 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.
• 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.