Senior Director, Clinical Data Mgmt

Job Description

The Senior Director is responsible and accountable for the organization and strategic direction of a Therapeutic Area in alignment within Executive Director, Project Data Management Services of GDMS. Ensures that sound data management principles are incorporated into the clinical research programs conducted or sponsored by our Research & Development Division in support of regulatory filings. Ensures consistent and standard data management processes in their functional area are used across our company's sites, as appropriate, and that processes meet worldwide regulatory guidelines. Performs within broad general policies and goals with minimal supervision. Responsibilities include interaction with individuals across multiple of our company's sites and may include supervision of global staff.

Primary activities include, but are not limited to:

• Directs all data management support activities within their therapeutic area. This may include responsibility for clinical research, clinical pharmacology, and epidemiology studies as well as non-project support.

• Being able to demonstrate the ability to work with external partners (Pharma, Bio Tech, Government Academia, CRO's) to deliver quality clinical data for submission.

• Aligns others around a positive direction. Under the guidance of the department head and/or their manager, develops high level, challenging, but achievable objectives that clearly support stated organizational goals. Forecasts short and long term resource needs, establishes measures to improve their area’s effectiveness and efficiency, and develops strategic plans.

• Develops career plans for direct reports (some of whom may be at the Associate Director level), makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides ongoing feedback on performance, provides rewards and recognition, and sets priorities.

• Provides developmental opportunities for employees, through management team or directly, including challenging growth assignments. Develops promotion strategies for their area. Ensures employees receive appropriate training and mentoring to be successful in their assignments.

• Provides advice and consultation on data management or functional area-specific activities to both internal (e.g., Clinical, Regulatory Affairs, BARDS, Human Resources, etc.) and external (e.g., clinical investigators, regulatory agencies, vendors, etc.) clients.

• Directs staff including Manager in the development, implementation, and documentation of standard operating procedures (SOPs) related to their area’s functions to ensure compliance with worldwide regulatory and relevant internal our company's requirements.

• May play a key role in the selection of in-house and external data management systems and the determination of work processes.

• May collaborate with data management groups from other divisions, companies, and agencies to ensure the validity and effectiveness of data management techniques and processes within GDMS

• Keeps abreast of new developments in the area of clinical data collection, processing, storage, and retrieval in order to provide guidance in the selection, enhancement, and maintenance of data management tools and processes.

• May lead or provide direction to a continuous improvement special project.

• May support any other project or perform any other data management or clinical operations task deemed appropriate by management.

Minimum education required:

• At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health Care, Computer Science or Engineering related discipline.

Required experience and skills:

• 10 years' experience in Clinical Development.

• 6 years' Data Management or related industry experience preferred.

• 5 years' experience and demonstrated success in personnel management, either directly (line reporting) or in a matrix environment.

• Working familiarity with the interactions between the businesses that comprise the pharmaceutical industry Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval), our company's products, and worldwide regulatory data management and reporting requirements.

• Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas.

• Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.

#ONEGDMS

#EligibleforERP

MRLGCTO

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Requisition ID:R243252