Associate Director, Clinical Development Trial Lead (CDTL) (W-2 Contract)

Arc Technologies Group, LLC•Stamford, CT

3d•Onsite

About The Position

The Associate Director, Clinical Development Trial Lead (CDTL) independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The Associate Director, CDTL consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of issues and resolution thereof. The role is a senior-level Clinical Development Trial Leader (CDTL) responsible for end-to-end project management of complex global clinical trials; including enrollment strategy, cross-functional team leadership, budget oversight, risk management, and CRO/TPO coordination. There is a preference for oncology experience across early and late phase programs. Candidates must bring 5+ years of clinical research experience, deep knowledge of cGCP and regulatory requirements, and the ability to independently drive trial execution across functions, geographies, and external partners. This is a contract W-2 position supporting a Fortune 100 global pharmaceutical company through Arc Technologies Group. The preferred location is onsite in Stamford, CT or Indianapolis, IN, with remote consideration available; if applying as a remote candidate, please apply to the appropriate listing. This listing is for the Stamford role. You will be a W-2 employee of ATG, embedded directly within the client's operations for the duration of the assignment. Pre-employment requirements include a background check, drug screening, and education verification. Client-specific onboarding and compliance steps will be discussed during the interview process, further information is provided at the end of this listing.

Requirements

Bachelor's degree (scientific or health-related field preferred)
5+ years clinical research experience or relevant experience in a scientific or health-related field
Deep knowledge of cGCP and regulatory requirements
Ability to independently drive trial execution across functions, geographies, and external partners
Applied knowledge of project management methodology, processes and tools
Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOs
Ability to influence without authority
Previous experience working in cross-functional teams/ projects and/or ability to establish and maintain relationships
Effective and influential communication, self-management, and organizational skills
Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity
Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
Prior clinical trial site-level or affiliate experience
Prior experience with local/country regional requirements
Strong analytical skills
Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI)
Ability to travel periodically to scientific/regional meetings
Work authorization in the United States

Nice To Haves

Oncology experience across early and late phase programs
Onsite at our Stamford, CT or Corporate Center in Indianapolis, IN. Remote options will be considered
Be recognized as a leader with demonstrated ability to coach others in process expertise.
Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities.

Responsibilities

Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT).
Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial.
Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.
Provide consultation and guidance to CDTLs on their integrated plans.
Assess, identify and monitor trial-level risks.
Understand the cross-functional, trial-level budget components. Create and monitor the budget grants and non-grants, and assumptions using financial tracking tools.
Routinely network with appropriate business partners on trial-level budget status and changes.
Function as point of contact for other CDTLs on their clinical team as needed regarding budget items.
Lead, influence and project manage large, complex studies and/or multiple smaller studies.
Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution.
Drive to solutions across the molecule/program.
Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET).
Partner with the Regional Operations to achieve regional enrollment goals.
Anticipate and resolve complex and key technical operational or business problems with cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners) with little to no need for direct management support.
Evaluate and identify issues that require escalation.
Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
Use expertise to make timely decisions for ambiguous and complex situations.
Manage TPO (third party organization) qualification process, selection, and oversight.
Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution.
Ensure CRO delivery of project milestones.
Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering regional needs.
Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial.
Look for opportunities to expand and deepen clinical trial process expertise across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution.
Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
Single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times.
Ensure inspection readiness of respective clinical trial(s).
Ensures timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics) and coaches CDTLs in these activities.
Network and apply expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver the clinical trial while reducing and/or mitigating risks, and share process learnings.
Contribute to the development of others by acting as a coach for peers as well as new CDTLs, cross-functional team members and TPOs on aspects of CT process and regional specificities.
Identify and lead process improvement activities.
Acts as a CDTL SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as science allows.
Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools.
Be instrumental in driving regional clinical operational processes and methodologies used.
Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and client standards of operation in the conduct of clinical trials.
Liaise with affiliates and other appropriate resources to understand local regulatory requirements.
Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution.
Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Combine scientific regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
Leverage clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Function as point of contact for Therapeutic Area and/or disease state expertise for others on their clinical team.