Company is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Company employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Company.
The Vice President (VP), Data Management provides positive leadership to effectively lead and manage the functions of Data Management including all activities within its domain. This is a leadership role that requires both strategic and tactical capabilities, excellence in business processes and innovation in problem solving and business growth initiatives. This role also provides support to business development activities, working with business development as needed to grow the client base, scope of work, and profitability of Company (AC) to meet financial and company goals.
The VP, Data Management serves as global head of Data Management and inclusive of data management, data review, database programming, and medical coding activities. The scope of responsibilities includes but is not limited to leadership, policy-making, global infrastructure development, personnel development, training and oversight, and regulatory guidance within the function. This position has a seat on the executive management committee and reports directly to the SVP, Clinical & Medical Operations. This role directs all aspects of Data Management including meeting all time frames and targets to the sponsor’s satisfaction. In addition, the VP is responsible for the execution of the scope of work, objectives, the quality of deliverables, and other data management, which may be multi-regional or international in scope. The VP is responsible to manage and report on the departmental budgets, forecasts, revenue stream, as well as profit and losses.
- Lead and develop strategic company initiatives.
- Understand the AC overall financial plan and contribute to and support of AC’s overall financial goals.
- Prepare and implement the Data Management department’s annual budgets and review and approve all respective department staff expense reports and timesheets, as well as invoices payable up to the agreed monetary limit.
- P&L oversight of the functional areas within Data Management departments
- Develop strategies and support directors, managers and other staff to drive programs according to agreed timelines; if changes are proposed to agreed milestones and timelines, to assist Data Management personnel in evaluating the risk of these decisions and developing plans to minimize/mitigate these risks.
- Accountable customer satisfaction related to Data Management deliverables.
- Oversee all aspects of Data Management departments including resource planning, deliverables, staff training, staff appraisals, performance reviews, and annual salary reviews.
- Execute strategy for continuing cross-departmental collaboration and company growth, and provide hands-on leadership to create a results-oriented, client focused, team environment.
- Initiate, lead, and develop strategic business growth initiatives, technology solutions, and or process improvements that improve efficiencies and global company growth.
- Attend capability and defense presentations with clients to support the development of new business.
- Attend RFI/RFP proposal strategy meetings and operationally lead strategy development and approve client proposals and budgets.
- Work closely with Quality and Compliance to ensure quality and continuous process improvement throughout the clinical and medical operations departments.
- Develop Data Management departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs.
- Adhere to strict code of confidentiality as it relates to study subjects, sponsors, physicians and policies and procedures.
- Effectively represent Data Management departments at project review meetings, quality review meetings, and other executive management meetings.
- The ideal candidate should have a minimum of 12 years’ experience in data management pharmaceutical development and a minimum of 7 years of management experience in a pharmaceutical company or CRO.
- Candidate must have experience in clinical trial design and be familiar with CDISC and regulatory requirements.
- Excellent oral and written communication skills, project and personnel management skills, and organizational skills are required.