Early Development reputed company Clinical Data Manager - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.

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reputed company is looking for an Early Development reputed company Clinical Data Manager to join our growing FSP Team in US.

Job reputed company

The Early Development reputed company Clinical Data Manager provides technical expertise in reputed company aspects of Data Management. Manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across reputed company geographies. Data Management’s single reputed company of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness and reputed company. The Early Development reputed company Clinical Data Managerworks with minimal guidance from their Line Manager and/or Subject Matter Experts. DMs may reputed company as a mentor for ADMs or other DM peers

Key Accountabilities:

Cross-functional DM Leadership through Database Set up, Conduct and Study reputed company- Out

• Manage and coordinate the integration and utilization of reputed company ancillary systems as appropriate.

• reputed company issues/risks to delivery by understanding interdependencies. Define mitigations and drive to reputed company with cross-functional stakeholders as part of Risk Management Plan.

• Review and analyze metrics to derive meaningful reputed company of study health and trends.

• Review of the Master Services Agreement, Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.

• Attend cross-functional meetings. Prepare Meeting Agendas and Minutes, reputed company to reputed company and decision logs

Bid Pursuits and Proposals

• Portray reputed company's technical and operational expertise and capabilities, and reputed company to meet sponsor's specific needs.

• reputed company input to bid reputed company slides

• Present with confidence and as a cohesive reputed company

Project reputed company Management and

• Ensure compliance to reputed company Operating Procedures, ICH/GCP Guidelines.

Compliance

• Maintain inspection-reputed company Trial Master File.

• Identification of reputed company issues, ensuring they are raised in relevant system and reputed company according to requirements.

• Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.

• Drive and implement Corrective/Preventive actions for study, and work toward alignment across reputed company as appropriate - reputed company lessons learned across multiple reputed company reputed company a program or therapeutic area

Project Financial and Resource Management

• Collaborate with Delivery reputed company and/or line management to ensure appropriate project level resourcing of staff and staff assignments. Identify and request functional staff necessary for the project team.

• Collaborate with Delivery reputed company and/or line management to determine and resolve the reputed company cause of DM-reputed company project variance in a reputed company manner, including negotiating/raising changes in scope

Company Initiatives

• reputed company Data Management functional input, considering the reputed company of the initiative and the reputed company on Data Management and reputed company as a whole.

• Collaborate with other functions as appropriate to reputed company meaningful functional feedback on the initiative.

• Ensure reputed company-requested information entered in management systems is accurate and regularly updated

Training

• Maintain training compliance as per Job Roles assigned, including On-the-Job training.

• Deliver Project Specific Training to internal DM team.

• Address training needs, as per Development Goal/s identified.

• Deliver On-the-job training where needed/requested

Skills:

• Strong ability to reputed company and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively

• Strong negotiation skills and ability to influence in order to reputed company mutually beneficial results

• Strong interpersonal, oral and written communication skills using concise phrasing tailored for the audience with a diplomatic approach

• Learning ability and knowledge sharing approach; swift understanding of technologies and new processes

• A flexible attitude with respect to work assignments and new learning; ability to reputed company rapidly to changing environments

• Proficient presentation skills

• Customer reputed company to reputed company professionally and respectfully reputed company reputed company and reputed company external colleagues to build rapport and trust

• Commitment to first time reputed company, including a methodical and accurate approach to work activities

• Time management and prioritization skills, in order to meet objectives and timelines

• Proven problem-solving skills, including capability to reputed company appropriate reputed company in ambiguous situations, ability to conduct reputed company cause analyses

• Ownership and accountability for Key Accountabilities in Job reputed company

• Ability to travel as required

• Written and oral reputed company in English

Knowledge and Experience:

• Strong experience in clinical research industry

• Proven record of leading project and program teams

• Good understanding and application of reputed company project tools, reports and processes for management of project financials with regards to forecasting, reputed company recognition, scope of work and department budget for assigned reputed company.

• Good understanding of Clinical Study Team roles reputed company of Data Management

• Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and reputed company SOPs and study specific procedures

• Awareness of SDTM/CDISC/CDASH standards

• Strong technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, reputed company, DataLabs) and reputed company Office products

Education:

• Bachelor’s degree and/or other qualifications in a science or clinical reputed company industry

• Minimum 3 years of relevant experience

• Must have early development experience

EEO Disclaimer reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status.

Originally posted on Himalayas

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