Manager, Clinical Data Management

Worldwide Clinical Trials; United States; Remote; USD 99,000 - 196,000; Full time

Job summary

Worldwide Clinical Trials is seeking a senior Data Management leader to oversee designated teams and projects, directing study execution and budget management within the Data Management department.

You will act as primary sponsor escalation contact, represent the company at governance meetings, and ensure staffing, training, and mentorship across the DM team while managing risks and resource plans.

Qualifications

• Excellent attention to detail.
• Excellent written and verbal communication skills.
• Expert knowledge of data management best practices & technologies as applied to clinical trials.
• Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.
• Advanced understanding of clinical trial process and protocols documents and processes.
• Independent analytical and problem solving skills.
• Strong project management skills and experience managing data management teams and projects for operational and budget oversight.
• Line management experience including recruitment, career development and performance reviews.

Responsibilities

• Provide management and leadership oversight of teams and projects within Data Management department for study execution and budget management.
• To act as the primary point of contact for any study specific escalations (internal or external).
• To represent the company at sponsor governance meetings.
• Manage assigned departmental personnel ensuring: staff are allocated to projects appropriately and according to their abilities/competencies; appropriate oversight, training and mentoring is provided; projects within the team are appropriately resourced; operational or budget risks are discussed and addressed; any performance related escalations for team member are managed and handled appropriately; highlight upcoming availability to DM Management to ensure continuity of utilisation.
• Define and monitor objectives for individual team members, ensuring there are opportunities for career and personal development.
• Provide support to Business Development staff by participating in preparation of proposals and presentations to sponsors.
• Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings.
• As required, perform the role of Subject Matter Expert for a specific DM process: Ongoing review to ensure the process is effective and efficient; Central point of contact for any related questions from the team; Provide ongoing training to all team members; Take ownership of any related Quality Issues identified, ensuring root cause analysis and CAPAs as required; Ownership and regular updates of related QMDs or other guidance documents; Provide mentorship to other members of the DM department; Lead and manage departmental initiatives for process improvement and efficiencies as defined by the DM Departmental leadership.

Skills

Attention to detail

Communication skills

Data management

Cross-functional collaboration

Clinical trials knowledge

Analytical skills

Project management

People management

Education

Bachelor's degree or higher in biomedical sciences or related

Job description

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 management and leadership oversight of assigned teams and projects within Data Management department for study execution and budget management. Support development and implementation of Worldwide processes and initiatives.

RESPONSIBILITIES

Tasks may include but are not limited to:

• Provide management and leadership oversight of teams and projects within Data Management department for study execution and budget management.
• To act as the primary point of contact for any study specific escalations (internal or external).
• Torepresentthe company at sponsor governance meetings.
• Manage assigned departmental personnel ensuring:
• staff areallocatedto projectsappropriatelyand according to their abilities/competencies
• appropriate oversight,trainingand mentoring is provided
• projects within the team are appropriately resourced
• operational or budget risks are discussed and addressed
• any performance related escalations for team member are managed and handled appropriately
• highlight upcoming availability to DM Management to ensure continuity of utilisation
• Define andmonitorobjectivesfor individual team members, ensuring there are opportunities for career and personal development.
• Provide support to Business Development staff byparticipatingin preparation of proposals and presentations to sponsors.
• Participate as necessary in sponsor audits, regulatory authority inspections and otherthird partymeetings. Ensure than any recommendations are discussed and that solutions are incorporated.
• As required, perform the role of Subject Matter Expert for a specific DM process:
• Ongoing review to ensure the process is effective and efficient.
• Central pointof contact for any related questions from the team.
• Provide ongoing training to all team members.
• Take ownership of any related Quality Issuesidentified, ensuring root cause analysis and CAPAs asrequired.
• Ownership and regular updates of related QMDs or other guidance documents.
• Provide mentorship to other members of the DM department.
• Lead and manage departmental initiatives for process improvement and efficiencies as defined by the DM Departmental leadership.

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

• Excellent attention to detail.
• Excellent written and verbal communication skills.
• Expert knowledge of data management best practices & technologies as applied to clinical trials.
• Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.
• Advanced understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Independent analytical andproblem solvingskills.
• Strong project management skills and experience managing data management teams and projects for operational and budget oversight
• Line management experience including recruitment, careerdevelopmentand performance reviews.

REQUIREMENTS

• Bachelor’s degree or higher in biomedical sciences, life sciences, computerscienceor related discipline — or equivalent relevant experience.
• Min of 9 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
• 2-4 years of line management experience.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility taken and ability to work independently.

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

United States of America - $99,000.00 - $196,000.00

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

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.