Senior Clinical Data Manager I

At Allucentxe2x84xa2 we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe We are looking for a Senior Clinical Data Manager I to join our A-team hybrid The Senior Clinical Data Manager I SrCDM1 is responsible for leading data management activities of the Allucent Data Management DM department This position manages coordinates reviews and approves DM deliverables from database design set-up through cleaning and reporting to database locking ensuring that the completeness accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting This position also provides expertise in relevant data management areas and cross-functional initiatives including the development of departmental processes tools and training of staff Position provides support in Request for Proposals RFPs and presents at Business Development BD Meetings This position is for the Chennai Location and not home-based In this role your key tasks will include Lead and serve as primary contact for DM with all relevant parties both internally e g Clinical Programmers Data Scientists Project Management Clinical Operations Monitoring Clinical Monitoring Biostatistics and other functional groups and externally e g sponsors vendors EDC external data and investigational sites Plan and project the resources required including management of tasks timelines risk and quality Monitor tasks against and keep track on budget forecasts and manage changes of scope budget revenue recognition Develop review and maintain project-specific DM documents including data management plan DMP eCRF specifications data validation plan DVP and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements Lead and coordinate the development of clinical study database set-up including eCRF design and database validation requirements Participate in the review of study documents e g protocol Project Plan safety plans manuals and statistical analysis plan lead and coordinate the review of electronic case report forms eCRFs Coordinate oversee and ensure the database User Acceptance Testing UAT related tasks are successfully completed Create training materials for EDC users and provide project-specific training as required Lead and oversee the review and validation of clinical data to ensure consistency accuracy integrity and completeness Create data cleaning strategy in consultation with applicable functional groups and oversee data releases such as for DETC DSMB IDMC interim and final locks updates after lock Perform and or coordinate various data transfers and reconciliation activities including but not limited to SAE PK and other external laboratory data Provide project metric reports status updates study progress feedback and advice to project team on site performance issues data trends and protocol non-compliance Organize and lead Quality Review activities during study Assist in project-related contracts negotiation and contracting process with vendors EDC IRT eCOA Manage the database maintenance lock and close-out processes and procedure Participate in conference calls and or meetings with vendors and sponsors Recognize and solve potential problems and evaluate effectiveness Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date Plan and create necessary documentation to support internal and external audits may participate in such audits assigned Help to align data management and clinical programming best practices standards and conventions within the company Provide leadership expertise and support to other department members Propose and support initiatives for improving efficiency Actively support to staff learning development within the company Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions Represent the company at professional meetings webinars or seminars Train and mentor data management staff support in development of new training material and provide training to relevant staff Participate in the interview process for new recruits Proactively track Data Management related regulatory development trends and updates in consultation with department Global Head and or Director for further alignment and improvement of current processes Contribute as Clinical Data Management Subject Matter Expert SME to the evaluation improvement drafting of processes and procedures within the Quality Management System Assure good communication and relationships with future clients Contribute to and take part in client evaluations and visits Support in preparation of new proposals and budgets for Data Management services Requirements To be successful you should possess Life science healthcare degree and or combination of education and experience Minimum 5 years of relevant work experience asa Clinical Data Manager Minimum 5 years of experience in drug development and or clinical research Thorough knowledge and understanding of ICH-GCP 21CFR11 data privacy GDPR HIPPA guidelines and awareness of local regional requirements Good understanding of Medical Terminology Experience with electronic data capture EDC software systems and other tools for managing clinical studies including IRT and eCOA Experience as DM lead on several studies preferably in different Therapeutic Areas and clinical development phases Experience in covering all phases of a clinical study start up conduct and database lock Thorough understanding of relational database components and experience in technical data management practices validation plans testing and documentation Experienced in CDISC conventions i e CDASH TAUG models and hands on experience implementing these models Experience in developing data management standards Strong written and verbal communication skills including a good command of the English language Representative outgoing and client-focused Ability to work in a fast-paced challenging environment of a growing company Proficiency with various computer applications such as Word Excel and PowerPoint required Administrative excellence Attention to detail strong technical analytical and problem-solving skills Strong project management skills Ability to translate guidelines rules and regulations in clear and usable recommendations Ability to simplify complex issues into understandable concepts Excellent organizational negotiating and motivational skills Benefits Benefits of working at Allucent include Comprehensive benefits package per location Competitive salaries per location Departmental Study Training Budget for furthering professional development Flexible Working hours within reason Opportunity for remote hybrid working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees Disclaimers Our hybrid work policy encourages a dynamic work environment prescribing 2 days in office per week for employees within reasonable distance from one of our The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent US LLC and its affiliates collectively Allucent Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency Candidates should never be submitted directly to our hiring managers employees or human resources