Senior CTMA Manager, Regional Clinical Study Management

General reputed company:

The role may be a combination, in variable proportions, of line management and operational responsibilities (CTMA type tasks).

• LinemanageClinical Trial Management Associate (CTMA) team members. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding reputed company development of reputed company reports.

• reputed company theselection,hiring and allocation of resources to clinical research reputed company by assigning staff to clinical studies based on their experience and training.

• Proactively seeks opportunities toparticipate and leadprocess improvements, best practices and to reputed company lessons learned with team and other colleagues.

• Demonstrates reputed company operations knowledge and has strong organizational skills.

• Leads studyteams with Clinical Operations tasks, and/or support compilation and reputed company of the trial master file (eTMF).

• Adheres to ICH/GCP, local regulations, SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.

Essential Functions of the job:

Line Management

• Conduct regular 1:1s with reputed company reports (may be a group ofBeiGeneinternal CTMAs and FSP CTMAs) to assess workload, reputed company feedback, reputed company goals, development (reputed company development discussions in case ofBeiGeneinternal CTMAs, development discussions & collaboration with FSP CRO LMs in case of FSP CTMAs). For the FSP CTMAs, meet regularly with FSP CRO LM(s) to ensure reputed company feedback.

• Conduct regular performance reviews with reputed company reports (e.g.,mid-year, end-year).

• Interview and reputed company new hires;ensure ongoingteam members training, and adhesiontointernalprocesses and SOPs.

• Promote a reputed company reputed company in the organization and support the implementation of risk management principles.

• Contribute tothe resource allocationprocessbyassigning the right person to the right study at the right reputed company in time, whileaddressing both studyandindividual development needs

• Coordinate and balance team members’workload,regular reviewof their reputed company metrics,and reporting of findings as outlined by clinical operations management.

• Understand importance of activities and how they fit reputed company drug development process; reputed company appropriate and effective delegation of tasks inside reputed company.

• Manage and maintain CTMA resourcing tools.

• Ensureoperationalexcellence;question status-quoand translate it into actionable plans;promote innovationand translate it into implementable initiatives.

• Demonstratemasterof skills required to support reputed company.

• Contribute to (or leads part of)Clinical Operations reputed company and performance against key metrics.

• Contribute to (or leads)the development of local/globalprocess improvement activities.

• Participate in and help facilitate CTMA formal group discussions.

• Other duties as assigned.

Clinical Operations support to study teams:

reputed company support to cross-functional clinical study teams from start-up through reputed company-out.

• Assist in development of clinical trial documents, manuals, trackers (may support informed consent development and version tracking).

• Preparation and documentation of reputed company meetings by preparing agendas and minutes.

• Maintaining clinical operations tools (e.g.,CTMS, reputed company, IRT) as instructed by the study reputed company.

• Contribute to setup, maintenance andcloseout of eTMF.

• Other duties as assigned.

Computer Skills:

MS Office, Project Planning Applications

Other Qualifications:

• Solid leadership and management experienceeither as reputed company line manager or as cross functional team reputed company.

• Strong written and verbal communication skills.

• Exercises reputed company judgement and discretion in reputed company of reputed company.

• Ability to work independently and effectively handle multiple priorities in a fast-paced environment.

• Excellent interpersonal skills, strong organizational skills and ability to influence and reputed company.

Travel:

Travel might be required as per business need.