Senior Manager, Bioanalytical Study Management

Requisition Number: 6318

Position Title: Senior Manager, Head of Bioanalytical Study Management

External 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 3,000 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 

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.   

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

 

 

SUMMARY: The Manager/ Senior Manager, Head of Bioanalytical Project Management will have direct oversight of the Bioanalytical Project Management Team and will play a key role in customer-facing and sponsor actives. This individual will lead a team of scientific project managers and will be responsible for training, mentoring, and assigning bioanalytical studies to his/her team.

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Develop strong working relationships and establish strong collaborations with other laboratory departments such as lab operations and scientific teams, to ensure quality and timelines for deliverables.
• Manage overall study portfolio; aide clients and staff in the proper planning and execution of studies. Serve as a liaison between the client and Worldwide. If issues arise, take an active role in resolving the issues promptly.
• Build up strong connections with Worldwide’s Business Development and Clinical Operations/Project Management teams, ensuring total customer satisfaction.
• Communicate regularly with clients to collect feedback on our services and help resolve issues in a manner that retains client’s confidence and repeat business.
• Lead and contribute to the client or authority’s inspections and assist in responding to the inspection questions such as deficiency letters or 483s related to Bioanalytical Study Manager’s studies.
• Serve as Laboratory Quality and Compliance Committee member and contribute to the decisions affecting the organization’s business.   
• Develop and consistently improve the scientific knowledge and work-flow/ process for the bioanalytical study management department, and
• Review and approve data and records associated with direct report studies.
• Make scientific judgments regarding the quality and integrity of data, takes corrective action, and documents the decision.
• Seek technical and management assistance when needed and use technical skills to troubleshoot.
• Ensure staff conducts the study following applicable SOPs, GLPs, and protocols.
• Ensure data, reports, and any supporting documentation required are delivered to the Sponsor by the agreed-upon date and with reasonable use of resources.
• Schedule and coordinate staff’s assigned projects.
• Ensure staff invoices projects promptly.
• Ensure quality of deliverables including data, reports, and electronic files.
• Ensure the study data and supporting records are archived promptly.
• Function as a Bioanalytical Study Manager as needed.
• Ensure that each employee in his/her group is assigned to duties that fall under direct labor and coordinate their schedules with other related personnel.
• Communicate to each employee in his/her group the job responsibilities and expectations for his/her position.
• Establish and monitor the work schedules for each employee in his/her group following company guidelines.
• Enforce company policies regarding the use of paid and unpaid leave and implement these policies consistently with all individuals in his/her group.
• Review and approve timesheets for all employees in his/her group.
• Monitor the performance of the employees in his/her group on an ongoing basis and make appropriate communications regarding performance to employees, management, and human resources.
• Develop a written plan with each employee in his/her group to set mutually agreed upon career goals.
• Actively develop staff through training, coaching, and mentoring in scientific, technical, and regulatory areas.
• Conduct all performance reviews for employees in his/her group to set and progress toward mutually agreed upon career goals.
• Make recommendations for promotions and salary increases for employees in his/her group.
• Counsel employees in his/her group that are not meeting the expectations of their position and provide them with notice of possible termination when necessary. These actions should be clearly documented, dated, and signed by the employee and the Associate Director.
• Terminate employees in his/her group when deemed necessary and provide supporting documentation to the Human Resources Department.
• Participate appropriately in the interview process.
• Follow established Worldwide Clinical Trials (Worldwide) policies and GLP regulations

• Ensure staff compliance with required training of departmental GLP, SOP, safety, and other guidelines.
• Contribute strategic scientific decisions affecting the department, particularly as related to project management.
• Contribute to unexpected investigations.
• Following safety procedures and guidelines.
• 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:

• Strong scientific background

• Demonstrates effective time management and interpersonal skills.
• Reviews project needs; estimates necessary manpower, funds, and facilities.
• Effectively monitors activities to ensure timelines are met.
• Works closely with Sponsors and Business Development to assess, reduce and/or manage risks with incoming programs.
• Ability to read, execute, and understand complicated and detailed instructions and technical literature to plan, perform, and direct laboratory activities.
• Strong scientific background.

REQUIREMENTS:

• Bachelor's degree, with a science focus, 12 plus years of related work experience, preferably in a Laboratory, or CRO, and five or more years of people management experience preferred, in lieu of people management experience the individual must demonstrate a strong ability to lead.
• D. preferred and 6+ years of direct or relatable experience as a Bioanalytical Study Manager

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Employment Type: Regular

Community / Marketing Title: Senior Manager, Bioanalytical Study Management

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Austin, Texas US

CountryEEOText_Description: 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 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. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.