Senior Manager, Document Management

761

Workplace Type: Remote

The Senior Manager, Document Management is a leadership role that supports the Document Management department. This role oversees TMF management, ensuring essential documents in the TMF are inspection-ready and are being maintained in compliance with regulatory guidelines and Advanced Clinical SOPs. The Senior Manager, Document Management requires both strategic and tactical capabilities, in addition to excellence in business processes and innovation in problem solving. The role has direct reports and manages those individuals regarding work commitments and deliverables, project timelines, quality objectives and resourcing allocations/assignments. The scope of responsibilities includes but is not limited to leadership, personnel development, training and oversight, and execution or support of projects within the TMF function. The Senior Manager, Document Management serves as a subject matter expert for Trial Master File standards, processes and electronic TMF systems.

Responsibilities: 

• Serve as a subject matter expert for TMF related topics, including essential documents, TMF management processes and TMF management systems (domestic and international requirements).
• Support implementation and management of electronic TMF applications and/or upgrades.
• Develop and maintain TMF-related SOPs and related documents (e.g. templates, forms, and other written instructions).
• Develop and maintain key performance indicators related to the management of TMFs.
• Monitor, analyze and use key performance indicators to drive timely completeness and accuracy of TMFs; includes leveraging key performance indicators as a means to identify and drive cross-functional process improvements within the organization.
• Ensure accurate processing and filing of essential documents in the TMF by assigned TMF staff per the current TMF Reference Model structure, SOPs and ICH-GCP guidelines.
• Oversee and ensure proper training of TMF staff and other end users (internal and external) to eTMF system functionality and other TMF-related topics.
• Develop strategies and support direct reports, functional team members and other staff to drive project deliverables to agreed timelines.
• Ensure TMF activities are conducted per client budgets and contracts; manage out of scope requests following internal processes.
• Collaborate with electronic TMF vendors as appropriate.
• Ensure routine distribution of TMF status updates to clinical study teams and senior leadership.
• If required, act as the TMF Manager / Lead on client projects
• Support department resourcing: hiring, performance management and evaluations, team development, mentoring and training, work assignments and allocations.
• Act as a key stakeholder and point of contact for TMF Management during internal or external audits/inspections, including facilitation of inspector access to TMFs and provision of audit/inspection responses, as required; includes assisting the Compliance & Quality team in audit/inspection preparation activities related to the TMF.
• When appropriate, attend industry conferences to advance TMF-related subject matter expertise.

Qualifications:

• A Bachelor’s Degree in healthcare or scientific discipline or equivalent combination of education and experience.
• Minimum 6 years professional experience working with clinical trial documentation and a minimum 2 years of experience in a leadership/people management capacity;
• Advanced knowledge of TMF industry standards, including thorough knowledge of all sections of the TMF Reference Model (current version).
• Strong experience and knowledge of electronic TMF applications for major non-proprietary system(s), such as Veeva Vault (strongly preferred), Trial Interactive and Phlexglobal.
• Excellent leadership skills and proven industry experience.
• Excellent communication and presentation skills, including written, spoken and listening skills.
• Ability to work in a fast-paced environment.
• Excellent organizational and problem-solving skills.
• Strong ability to work with individuals across various levels of the organization, as well as individuals outside of the organization.
• Strong computer skills, including Power Point, Excel, Word etc.
• Ability to travel as required, up to 20%.

Role Competencies:

• Proficiency of the skills and knowledge relevant to the function. Success in performing most complex assignments with little supervision.
• Communicates complex issues clearly and credibly with widely varied audiences. Ensures appropriate individuals are informed.
• Proactively discovers the needs of customers and creates new solutions, services, and processes to meet the customer's changing needs. Works in partnership to improve customer experience.
• Ensures the establishment of adequate data gathering and analysis policies and procedures. Uses systems thinking to investigate the complex relationships between seemingly unrelated issues and considers the wider context in order to make solid conclusions.
• Develops, recommends, and implements new regulations/policies or changes. Understands, identifies, and resolves complex financial issues.
• Develops consensus and alignment on ideas and recommendations affecting own team or other teams. Facilitates discussions and gives consideration to a range of interests, opinions, possibilities and situational variables.
• Creates new and relevant ideas and leads others to implement them. Challenges convention purposefully. Critically assesses established methods.
• Demonstrates awareness, flexibility and willingness to adapt approach and/or apply different leadership styles when the situation or individual requires it. Can test assumptions and own stories by seeking ideas and stories of others. Depicts high level of self-discipline.
• Establishes reputation as a credible and trustworthy source for employees to voice concerns and share anything that might be negatively impacting their competence and commitment on current goals and tasks. Identifies and responds to underlying attitudes or behavior patterns such as cultural norms and personality differences. Reacts purposefully to frustrations of others. Resolves escalated conflicts among stakeholders through effective dialogue.
• Accepts constructive feedback and adapts leadership style/actions/behaviors. Creates a sense of wellbeing by taking an active interest in the opinions and ideas of others and partnering in efforts to align. Plays to the different strengths and development levels within a team to maximize effectiveness. Helps others through emotional or tense situations, tactfully bringing disagreements into the open, engaging in healthy debate.
• Facilitates the creation of effective SMART goals by team members, ensuring they tie to wider team and company strategies. Stays knowledgeable on industry trends. Anticipates outcomes of decisions made by the business based on experience and following trends. Monitors financial performance and efficiency of own team.
• Help and encourage others to identify and leverage transferrable skills and develop the goal or job specific skills necessary for current and future roles. Able to diagnose development level on goals and tasks and provide the matching leadership style to build competence and commitment, thereby accelerating development.
• Establish strategies or methods for accomplishing major new directives. Keeps informed on trends in the industry and develops strategies to realize opportunities or mitigate risks.
• Swiftly administers action if needed and deals with difficult questions head on. Commits to completely new activities that are innovative and feasible or styles of approach that are necessary but feel less comfortable. Measures the risks involved while taking a course of action.
• Holds self and team accountable to upholding the REAL values. Integrate the REAL values into team processes. Celebrate when witnessing team members exhibiting these values.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation.  Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

EEO Employer Verbiage:

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.