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Cape Town, Western Cape, South Africa
Remote only
Who we are
We’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 Worldwide
We 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 essential.
Proven ability to design and/or develop Data Management solutions deployed in clinical trials.
Good knowledge of guidelines and regulations relevant to the deployment of technologies and programming in clinical development programs.
Excellent Time Management skills with ability to develop, follow and direct project plans.
Excellent knowledge of budgets, revenue recognition, and invoicing.
Organizational skills that define strategies in a way that align and contribute to the organization’s strategic plan.
Proven ability to prioritise and handle multiple projects simultaneously, a flexible and creative approach, the ability to use sound independent judgement and take initiative to assess information
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.