Senior Director, Data Management - South Africa - Remote
Lifelancer
29d ago
0ManagementUnited Stateshimalayas
Data-ManagementClinical-OperationsClinical-ResearchDatabase-ProgrammingDrug-DevelopmentSenior-Data-ManagerSenior-Data-Governance-ManagerData-Management-LeadSenior-Director-Clinical-Data-ManagementDirectorExecutive
Job Description
Job Title: Senior Director, Data Management - South Africa - RemoteJob Location: Cape Town, South AfricaJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: Who we areWe’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.Why WorldwideWe believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!SUMMARY: To provide strategic leadership and technical expertise to the Data Management department. To establish the optimal operational framework for the department ensuring data management deliverables are completed to a high quality and within agreed timelines** leveraging and anticipating regulatory and industry changes.
RESPONSIBILITIES:Tasks may include but are not limited to:
Provide global innovative and creative leadership of the department, across several sites and countries, including setting strategic direction and leading change.
Plan and develop overall strategies for the future of the Data Management and Database Programming department including system and resource needs.
Assume overall responsibility for the efficiency of the Data Management department, utilizing metrics on quality and efficiency and feedback from internal and external customers.
Monitor departmental budgets and have oversight of project PPR’s, ensuring DM staff are adhering to trial budgets and timelines
To be responsible for staff allocation within the Department, ensuring sufficient expertise and delegating responsibility appropriately.
Supervise, coach and mentor Data Management staff, undertaking performance appraisals and development reviews as appropriate.
Identify the Department’s training requirements and to provide or source training as and when required.
Provide expert advice on Data Management issues for either general processes or project specific details.
Design solutions to enable Data Management, and to ensure related clinical trial management and clinical data requirements are met
Ensure self and team liaise with technology and other scientific/medical colleagues
Point of contact and escalation for Sponsor personnel.
Ensure that Data Management departmental SOPs and other non-project-specific procedures/ working guidelines are written and updated as required.
Ensure the Data Management team performs in accordance with Good Clinical Practice guidelines, departmental SOPs, and guidelines, and to the agreed requirements of the Sponsor.
Ensure support is provided to all Business Development activities including input and review of bids and proposals and representing Data Management at Bid Defence meetings.
Provide technical advice and support on Data Management topics to other departments.
Represent Data Management within Worldwide, ensuring that the department’s capabilities and expertise are well represented.
To fully co-operate with the auditors of the Sponsor company and any other staff from the regulatory authorities both during and after the project to ensure that any recommendations are discussed with senior management as appropriate and that any recommendations are incorporated
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
*OTHER SKILLS AND ABILITIES:*
A good standard of written and spoken English
Excellent time management skills with ability to work to and direct project plans
Ability to prioritize and handle multiple projects simultaneously; flexible and able to use sound independent judgment and take initiative to assess information
Proven leadership and management skills
Excellent working knowledge of Data Management Systems and principles
*REQUIREMENTS:*
Educated to degree level or equivalent
12 relevant Data Management experience.
Clinical drug development experience including experience in software or application development and deployment.
Excellent written and verbal communication skills and strong attention to detail are
