Sr. Scientist, Clinical Operations (REMOTE)

Job Description

Activities

Develops program and study-level feasibility and operational parameters: Via analysis of evidence, uses, and may develop, specialized methodology to project program/study milestones, create site selection criteria, and establish need for patient recruitment and retention strategies and tactics. Collaborates with CSSM to align on deliverables. (25%)

Develops and recommends program and study-level recruitment and retention plan: Develops study-level patient outreach and recruitment vendor strategies, and, in collaboration with CSSM PL or SM, develops implementation plans for delivery of recruitment and retention strategies and tactics in compliance with federal and local country regulations. (25%)

Project management of Recruitment Tactics: the Sr. GTOS creates an execution plan for program and study-level recruitment and retention tactics. Includes country specific details and ranges of contribution for each tactic. In collaboration with program, study leads manage the implementation of these tactics especially related to recruitment and media vendors. (30%)

Personal and Professional Development: Attends training and conferences in Patient recruitment and retention, feasibility and other related topics to bring greater skills and depth of knowledge to bear on the GTO function. (10%)

Contributes to training, and process improvement: Provides leadership to less experienced GTOS by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training, mentorship and instructions on GTO methods and guides others re: application of informatics, simulation, and modeling. Provides training on systems and tools which support Global Trial Optimization activities; inclusive of applications of performance metrics for Global Trial Optimization in order to leverage internal and external intelligence and support/refine methods and tactics on assigned projects. Maintain relationships with system and tool vendors and research new tools to enhance data capabilities. (10%)

Impact:
Under the supervision of their manager, the Sr. GTOS identifies for the CSSM organization strategies and tactics that will be used for identification, qualification, selection and preparation of sites and for recruitment and retention of patients in our clinical trials. Participates in early identification of potential risks to those objectives. Participates in developing and implementing mitigation strategies when needed. Collaborates with manager to align the operational execution plan with divisional scorecard objectives.

Decision Making:
The Sr. GTOS conducts operational analyses and planning to ensure that patient recruitment strategies and tactics identified for a program/study are practical, experienced based and cost effective to execute. In collaboration with their management chain, the GTOS finalizes deliverables and identifies potential areas for process improvement.

Problem Solving:
The Sr. GTOS must have strong analytical skills and be able to synthesize data and differing points of view to navigate to an evidence-based data driven solution. They must be able to negotiate and influence stakeholders. Assessing the gaps between desired and feasible operational outcomes of clinical development programs, developing solutions to these, and then successfully promoting them are key skills.

Expertise:

The Sr. GTOS should possess a Bachelor or Master of Science degree in medical/pharmaceutical/biological sciences with at least 5 years of career experience including 3-5 years’ experience in the conduct of clinical trials and some knowledge in business process analytics and continuous improvement. Desired skills include formal education and or training in medical, marketing, and/or communication. An ability to analyze clinical data and synthesize medical evidence into a plan is a strength. The incumbent needs to have demonstrated administrative and project management abilities in a relevant clinical development setting. The incumbent must have excellent interpersonal and communication skills preferably practiced in an international clinical research environment.

Leadership:

The Sr. GTOS must be able to communicate and express ideas clearly, orally and in writing, to develop operational parameters, Recruitment and retention plans and other key GTO deliverables. They will represent GTO, with support from GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational Review. They must be able, with appropriate support, to influence team colleagues through data driven argument. In general, will collaborate with